Quality Compliance Management — M2

Goal templates — Quality Compliance Management — M2

Quality Assurance & Compliance · Quality Compliance Management · M2 — Manager II

These are canon-derived frames, not advice: every line is either verbatim JobFrame canon text or a fixed template wrapping it. ⟨target⟩ / ⟨baseline⟩ / ⟨date⟩ are placeholders for the manager to fill in. Nothing here is generated by AI — rows are omitted, never invented, when the canon lacks the underlying field.

SMART goals

One row per canon core output / responsibility this level owns.

JFM responsibility (M2)

Manages a skilled team of compliance specialists and/or junior compliance managers, owning tactical outcomes for QMS maintenance and audit readiness within known regulatory factors

Specific
Deliver: "Manages a skilled team of compliance specialists and/or junior compliance managers, owning tactical outcomes for QMS maintenance and audit readiness within known regulatory factors"
Measurable
Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
Achievable
Scoped to this level's jfm complexity/problem-solving rubric: "Exercises judgment within known regulatory factors; investigates non-conformances and resolves audit findings where root cause is not yet established."
Relevant
Advances the Quality Assurance & Compliance · Quality Compliance Management mandate for a M2 — Manager II.
Time-bound
⟨date⟩

JFM responsibility (M2)

Identifies compliance issues requiring follow-up and directs the internal investigation of non-conformances to closure

Specific
Deliver: "Identifies compliance issues requiring follow-up and directs the internal investigation of non-conformances to closure"
Measurable
Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
Achievable
Scoped to this level's jfm complexity/problem-solving rubric: "Exercises judgment within known regulatory factors; investigates non-conformances and resolves audit findings where root cause is not yet established."
Relevant
Advances the Quality Assurance & Compliance · Quality Compliance Management mandate for a M2 — Manager II.
Time-bound
⟨date⟩

JFM responsibility (M2)

Oversees internal and supplier audits, coordinating audit closure and verification of corrective actions across the team's portfolio

Specific
Deliver: "Oversees internal and supplier audits, coordinating audit closure and verification of corrective actions across the team's portfolio"
Measurable
Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
Achievable
Scoped to this level's jfm complexity/problem-solving rubric: "Exercises judgment within known regulatory factors; investigates non-conformances and resolves audit findings where root cause is not yet established."
Relevant
Advances the Quality Assurance & Compliance · Quality Compliance Management mandate for a M2 — Manager II.
Time-bound
⟨date⟩

JFM responsibility (M2)

Drives CAPA execution — assigning root cause analysis (5 Whys, Ishikawa, 8D) and verifying effectiveness — for issues surfaced within the unit

Specific
Deliver: "Drives CAPA execution — assigning root cause analysis (5 Whys, Ishikawa, 8D) and verifying effectiveness — for issues surfaced within the unit"
Measurable
Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
Achievable
Scoped to this level's jfm complexity/problem-solving rubric: "Exercises judgment within known regulatory factors; investigates non-conformances and resolves audit findings where root cause is not yet established."
Relevant
Advances the Quality Assurance & Compliance · Quality Compliance Management mandate for a M2 — Manager II.
Time-bound
⟨date⟩

JFM responsibility (M2)

Coordinates cross-functionally with manufacturing and engineering peers to address recurring non-compliance issues and to standardize quality practices

Specific
Deliver: "Coordinates cross-functionally with manufacturing and engineering peers to address recurring non-compliance issues and to standardize quality practices"
Measurable
Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
Achievable
Scoped to this level's jfm complexity/problem-solving rubric: "Exercises judgment within known regulatory factors; investigates non-conformances and resolves audit findings where root cause is not yet established."
Relevant
Advances the Quality Assurance & Compliance · Quality Compliance Management mandate for a M2 — Manager II.
Time-bound
⟨date⟩
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1. Manages a skilled team of compliance specialists and/or junior compliance managers, owning tactical outcomes for QMS maintenance and audit readiness within known regulatory factors  [source: JFM responsibility (M2)]
   Specific:    Deliver: "Manages a skilled team of compliance specialists and/or junior compliance managers, owning tactical outcomes for QMS maintenance and audit readiness within known regulatory factors"
   Measurable:  Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
   Achievable:  Scoped to this level's jfm complexity/problem-solving rubric: "Exercises judgment within known regulatory factors; investigates non-conformances and resolves audit findings where root cause is not yet established."
   Relevant:    Advances the Quality Assurance & Compliance · Quality Compliance Management mandate for a M2 — Manager II.
   Time-bound:  ⟨date⟩

2. Identifies compliance issues requiring follow-up and directs the internal investigation of non-conformances to closure  [source: JFM responsibility (M2)]
   Specific:    Deliver: "Identifies compliance issues requiring follow-up and directs the internal investigation of non-conformances to closure"
   Measurable:  Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
   Achievable:  Scoped to this level's jfm complexity/problem-solving rubric: "Exercises judgment within known regulatory factors; investigates non-conformances and resolves audit findings where root cause is not yet established."
   Relevant:    Advances the Quality Assurance & Compliance · Quality Compliance Management mandate for a M2 — Manager II.
   Time-bound:  ⟨date⟩

3. Oversees internal and supplier audits, coordinating audit closure and verification of corrective actions across the team's portfolio  [source: JFM responsibility (M2)]
   Specific:    Deliver: "Oversees internal and supplier audits, coordinating audit closure and verification of corrective actions across the team's portfolio"
   Measurable:  Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
   Achievable:  Scoped to this level's jfm complexity/problem-solving rubric: "Exercises judgment within known regulatory factors; investigates non-conformances and resolves audit findings where root cause is not yet established."
   Relevant:    Advances the Quality Assurance & Compliance · Quality Compliance Management mandate for a M2 — Manager II.
   Time-bound:  ⟨date⟩

4. Drives CAPA execution — assigning root cause analysis (5 Whys, Ishikawa, 8D) and verifying effectiveness — for issues surfaced within the unit  [source: JFM responsibility (M2)]
   Specific:    Deliver: "Drives CAPA execution — assigning root cause analysis (5 Whys, Ishikawa, 8D) and verifying effectiveness — for issues surfaced within the unit"
   Measurable:  Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
   Achievable:  Scoped to this level's jfm complexity/problem-solving rubric: "Exercises judgment within known regulatory factors; investigates non-conformances and resolves audit findings where root cause is not yet established."
   Relevant:    Advances the Quality Assurance & Compliance · Quality Compliance Management mandate for a M2 — Manager II.
   Time-bound:  ⟨date⟩

5. Coordinates cross-functionally with manufacturing and engineering peers to address recurring non-compliance issues and to standardize quality practices  [source: JFM responsibility (M2)]
   Specific:    Deliver: "Coordinates cross-functionally with manufacturing and engineering peers to address recurring non-compliance issues and to standardize quality practices"
   Measurable:  Move the metric this drives from ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩.
   Achievable:  Scoped to this level's jfm complexity/problem-solving rubric: "Exercises judgment within known regulatory factors; investigates non-conformances and resolves audit findings where root cause is not yet established."
   Relevant:    Advances the Quality Assurance & Compliance · Quality Compliance Management mandate for a M2 — Manager II.
   Time-bound:  ⟨date⟩

OKRs

Objectives from this level's core outputs; key results only where a real dimension or capability backs them.

JFM responsibility (M2)

Manages a skilled team of compliance specialists and/or junior compliance managers, owning tactical outcomes for QMS maintenance and audit readiness within known regulatory factors

  • From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Manages a skilled team of compliance specialists and/or junior compliance managers, owning tactical outcomes for QMS maintenance and audit readiness within known regulatory factors"
  • Evidence at this level's scope bar: "An established team or sub-function" — ⟨target⟩ by ⟨date⟩

JFM responsibility (M2)

Identifies compliance issues requiring follow-up and directs the internal investigation of non-conformances to closure

  • From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Identifies compliance issues requiring follow-up and directs the internal investigation of non-conformances to closure"
  • Evidence at this level's autonomy bar: "Owns planning for the group" — ⟨target⟩ by ⟨date⟩

JFM responsibility (M2)

Oversees internal and supplier audits, coordinating audit closure and verification of corrective actions across the team's portfolio

  • From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Oversees internal and supplier audits, coordinating audit closure and verification of corrective actions across the team's portfolio"
  • Evidence at this level's complexity bar: "Cross-project coordination and priorities" — ⟨target⟩ by ⟨date⟩

JFM responsibility (M2)

Drives CAPA execution — assigning root cause analysis (5 Whys, Ishikawa, 8D) and verifying effectiveness — for issues surfaced within the unit

  • From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Drives CAPA execution — assigning root cause analysis (5 Whys, Ishikawa, 8D) and verifying effectiveness — for issues surfaced within the unit"
  • Evidence at this level's impact bar: "Group delivery and development" — ⟨target⟩ by ⟨date⟩

JFM responsibility (M2)

Coordinates cross-functionally with manufacturing and engineering peers to address recurring non-compliance issues and to standardize quality practices

  • From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Coordinates cross-functionally with manufacturing and engineering peers to address recurring non-compliance issues and to standardize quality practices"
  • Evidence at this level's decision rights bar: "Owns staffing, priorities, performance for the group" — ⟨target⟩ by ⟨date⟩
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Objective 1: Manages a skilled team of compliance specialists and/or junior compliance managers, owning tactical outcomes for QMS maintenance and audit readiness within known regulatory factors  [source: JFM responsibility (M2)]
  KR1. From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Manages a skilled team of compliance specialists and/or junior compliance managers, owning tactical outcomes for QMS maintenance and audit readiness within known regulatory factors"
  KR2. Evidence at this level's scope bar: "An established team or sub-function" — ⟨target⟩ by ⟨date⟩

Objective 2: Identifies compliance issues requiring follow-up and directs the internal investigation of non-conformances to closure  [source: JFM responsibility (M2)]
  KR1. From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Identifies compliance issues requiring follow-up and directs the internal investigation of non-conformances to closure"
  KR2. Evidence at this level's autonomy bar: "Owns planning for the group" — ⟨target⟩ by ⟨date⟩

Objective 3: Oversees internal and supplier audits, coordinating audit closure and verification of corrective actions across the team's portfolio  [source: JFM responsibility (M2)]
  KR1. From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Oversees internal and supplier audits, coordinating audit closure and verification of corrective actions across the team's portfolio"
  KR2. Evidence at this level's complexity bar: "Cross-project coordination and priorities" — ⟨target⟩ by ⟨date⟩

Objective 4: Drives CAPA execution — assigning root cause analysis (5 Whys, Ishikawa, 8D) and verifying effectiveness — for issues surfaced within the unit  [source: JFM responsibility (M2)]
  KR1. From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Drives CAPA execution — assigning root cause analysis (5 Whys, Ishikawa, 8D) and verifying effectiveness — for issues surfaced within the unit"
  KR2. Evidence at this level's impact bar: "Group delivery and development" — ⟨target⟩ by ⟨date⟩

Objective 5: Coordinates cross-functionally with manufacturing and engineering peers to address recurring non-compliance issues and to standardize quality practices  [source: JFM responsibility (M2)]
  KR1. From ⟨baseline⟩ to ⟨target⟩ by ⟨date⟩ — tied to: "Coordinates cross-functionally with manufacturing and engineering peers to address recurring non-compliance issues and to standardize quality practices"
  KR2. Evidence at this level's decision rights bar: "Owns staffing, priorities, performance for the group" — ⟨target⟩ by ⟨date⟩

MBO areas

Key result areas from this level's responsibilities, each with a standard grounded in the canon leveling rubric where one exists.

AreaStandardTargetDue
Manages a skilled team of compliance specialists and/or junior compliance managers, owning tactical outcomes for QMS maintenance and audit readiness within known regulatory factorsConsistent with this level's jfm knowledge-application rubric: "Applies regulatory knowledge (FDA QSR, ISO 13485, Part 11) and formal investigation/CAPA methods to direct a skilled team's tactical outcomes."⟨target⟩⟨date⟩
Identifies compliance issues requiring follow-up and directs the internal investigation of non-conformances to closureConsistent with this level's jfm knowledge-application rubric: "Applies regulatory knowledge (FDA QSR, ISO 13485, Part 11) and formal investigation/CAPA methods to direct a skilled team's tactical outcomes."⟨target⟩⟨date⟩
Oversees internal and supplier audits, coordinating audit closure and verification of corrective actions across the team's portfolioConsistent with this level's jfm knowledge-application rubric: "Applies regulatory knowledge (FDA QSR, ISO 13485, Part 11) and formal investigation/CAPA methods to direct a skilled team's tactical outcomes."⟨target⟩⟨date⟩
Drives CAPA execution — assigning root cause analysis (5 Whys, Ishikawa, 8D) and verifying effectiveness — for issues surfaced within the unitConsistent with this level's jfm knowledge-application rubric: "Applies regulatory knowledge (FDA QSR, ISO 13485, Part 11) and formal investigation/CAPA methods to direct a skilled team's tactical outcomes."⟨target⟩⟨date⟩
Coordinates cross-functionally with manufacturing and engineering peers to address recurring non-compliance issues and to standardize quality practicesConsistent with this level's jfm knowledge-application rubric: "Applies regulatory knowledge (FDA QSR, ISO 13485, Part 11) and formal investigation/CAPA methods to direct a skilled team's tactical outcomes."⟨target⟩⟨date⟩
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1. Area: Manages a skilled team of compliance specialists and/or junior compliance managers, owning tactical outcomes for QMS maintenance and audit readiness within known regulatory factors  [source: JFM responsibility (M2) — reused, no distinct responsibility content]
   Standard: Consistent with this level's jfm knowledge-application rubric: "Applies regulatory knowledge (FDA QSR, ISO 13485, Part 11) and formal investigation/CAPA methods to direct a skilled team's tactical outcomes."
   Target:   ⟨target⟩   Due: ⟨date⟩

2. Area: Identifies compliance issues requiring follow-up and directs the internal investigation of non-conformances to closure  [source: JFM responsibility (M2) — reused, no distinct responsibility content]
   Standard: Consistent with this level's jfm knowledge-application rubric: "Applies regulatory knowledge (FDA QSR, ISO 13485, Part 11) and formal investigation/CAPA methods to direct a skilled team's tactical outcomes."
   Target:   ⟨target⟩   Due: ⟨date⟩

3. Area: Oversees internal and supplier audits, coordinating audit closure and verification of corrective actions across the team's portfolio  [source: JFM responsibility (M2) — reused, no distinct responsibility content]
   Standard: Consistent with this level's jfm knowledge-application rubric: "Applies regulatory knowledge (FDA QSR, ISO 13485, Part 11) and formal investigation/CAPA methods to direct a skilled team's tactical outcomes."
   Target:   ⟨target⟩   Due: ⟨date⟩

4. Area: Drives CAPA execution — assigning root cause analysis (5 Whys, Ishikawa, 8D) and verifying effectiveness — for issues surfaced within the unit  [source: JFM responsibility (M2) — reused, no distinct responsibility content]
   Standard: Consistent with this level's jfm knowledge-application rubric: "Applies regulatory knowledge (FDA QSR, ISO 13485, Part 11) and formal investigation/CAPA methods to direct a skilled team's tactical outcomes."
   Target:   ⟨target⟩   Due: ⟨date⟩

5. Area: Coordinates cross-functionally with manufacturing and engineering peers to address recurring non-compliance issues and to standardize quality practices  [source: JFM responsibility (M2) — reused, no distinct responsibility content]
   Standard: Consistent with this level's jfm knowledge-application rubric: "Applies regulatory knowledge (FDA QSR, ISO 13485, Part 11) and formal investigation/CAPA methods to direct a skilled team's tactical outcomes."
   Target:   ⟨target⟩   Due: ⟨date⟩

Scorecard

Only perspectives with real canon backing are shown — no Financial or Customer perspective, since nothing in the canon grounds business-financial or customer measures for a role alone.

Internal process

  • "Manages a skilled team of compliance specialists and/or junior compliance managers, owning tactical outcomes for QMS maintenance and audit readiness within known regulatory factors"⟨target⟩ by ⟨date⟩
  • "Identifies compliance issues requiring follow-up and directs the internal investigation of non-conformances to closure"⟨target⟩ by ⟨date⟩
  • "Oversees internal and supplier audits, coordinating audit closure and verification of corrective actions across the team's portfolio"⟨target⟩ by ⟨date⟩
  • "Drives CAPA execution — assigning root cause analysis (5 Whys, Ishikawa, 8D) and verifying effectiveness — for issues surfaced within the unit"⟨target⟩ by ⟨date⟩
  • "Coordinates cross-functionally with manufacturing and engineering peers to address recurring non-compliance issues and to standardize quality practices"⟨target⟩ by ⟨date⟩

Role calibration

  • Meets the scope bar: "An established team or sub-function"⟨target⟩ by ⟨date⟩
  • Meets the autonomy bar: "Owns planning for the group"⟨target⟩ by ⟨date⟩
  • Meets the complexity bar: "Cross-project coordination and priorities"⟨target⟩ by ⟨date⟩
  • Meets the impact bar: "Group delivery and development"⟨target⟩ by ⟨date⟩
  • Meets the decision rights bar: "Owns staffing, priorities, performance for the group"⟨target⟩ by ⟨date⟩
  • Meets the leadership bar: "Manages a team; sometimes manages leads"⟨target⟩ by ⟨date⟩
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Internal process
  - "Manages a skilled team of compliance specialists and/or junior compliance managers, owning tactical outcomes for QMS maintenance and audit readiness within known regulatory factors"  →  ⟨target⟩ by ⟨date⟩   [source: JFM responsibility (M2)]
  - "Identifies compliance issues requiring follow-up and directs the internal investigation of non-conformances to closure"  →  ⟨target⟩ by ⟨date⟩   [source: JFM responsibility (M2)]
  - "Oversees internal and supplier audits, coordinating audit closure and verification of corrective actions across the team's portfolio"  →  ⟨target⟩ by ⟨date⟩   [source: JFM responsibility (M2)]
  - "Drives CAPA execution — assigning root cause analysis (5 Whys, Ishikawa, 8D) and verifying effectiveness — for issues surfaced within the unit"  →  ⟨target⟩ by ⟨date⟩   [source: JFM responsibility (M2)]
  - "Coordinates cross-functionally with manufacturing and engineering peers to address recurring non-compliance issues and to standardize quality practices"  →  ⟨target⟩ by ⟨date⟩   [source: JFM responsibility (M2)]

Role calibration
  - Meets the scope bar: "An established team or sub-function"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Scope)]
  - Meets the autonomy bar: "Owns planning for the group"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Autonomy)]
  - Meets the complexity bar: "Cross-project coordination and priorities"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Complexity)]
  - Meets the impact bar: "Group delivery and development"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Impact)]
  - Meets the decision rights bar: "Owns staffing, priorities, performance for the group"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Decision rights)]
  - Meets the leadership bar: "Manages a team; sometimes manages leads"  →  ⟨target⟩ by ⟨date⟩   [source: level dimension (Leadership)]
Quality Compliance Management — M2 · M2 — Manager II — goal templates — People Analytics Toolbox