Manager, Quality

Field

Controlled Definition

Role Code

00004-2

Department / Function

Quality

Reports To

Head of Quality or Director, Quality

Direct Reports

Associate/Senior Associate, Quality and Regulatory Affairs as assigned

Employment Level

Manager

Role Purpose

Lead or perform independent Quality Control Unit, Quality Assurance, Quality Systems, document control, training governance, supplier quality, validation/CSV Quality, data integrity, complaints/recalls and product/material disposition at the Manager level. First-line Quality-system and Quality-operations leader. Ad hoc member of the SERC team

Essential Responsibilities

• Review GMP records and evidence for compliance, completeness and traceability.
• Support/own deviations, CAPA, change control, complaints, quality metrics and inspection readiness.
• Maintain controlled procedures, specifications, records and quality-system interfaces.
• Apply independent quality judgment; resist schedule/revenue pressure and escalate conflicts affecting product quality or patient safety.
• Own day-to-day process/team execution, work assignment, scheduling and first-line supervision; assign only qualified personnel to controlled activities.
• Maintain department procedures, metrics, training plans, risk registers and resource forecasts for the assigned function.
• Review work quality, deviations/issues and recurring performance trends; lead corrective actions and escalate systemic risk.
• Develop Associates/Senior Associates, maintain backup coverage and recommend authorization/promotion based on evidence rather than tenure.
• Represent the function in cross-functional meetings, inspections, projects and SERC-supporting workstreams as assigned.
• Exercise only specifically documented QCU approvals/delegations for which qualification and authority are current; maintain independence from Operations and commercial pressure.

Decision Rights / Boundaries

Authority is limited to the approved JD, documented delegation and task/system authorization. Title alone does not grant QCU, PIC or GMP-system approval rights. May exercise defined QCU approvals only when formally delegated by the Head of Quality and currently qualified.

Minimum Qualification Profile

Bachelor's degree in life science, pharmacy, engineering or related discipline preferred; equivalent relevant GMP experience may be considered. Current GMP/GDP/data-integrity training and role-specific qualification are required.

Preferred / developmental credentials: ASQ CQA/CQE/CMQ-OE, RAC or equivalent quality/regulatory credential may support development; none substitutes for demonstrated competency or QCU delegation.

Career Development / Readiness for Next Level

Typical 12-24 month development to Director consideration: sustained end-to-end system ownership; cross-functional leadership; audit/inspection or major-project leadership; resource/budget/capacity judgment; qualified backups/succession; measurable process improvement; and advanced functional education/credential where valuable. Director scope must exist; tenure alone does not qualify.

Initial / Continuing Training Expectations

Complete the applicable department curriculum in Section 4, role/JD review, controlled procedures, system/equipment training, competency assessments and task authorizations. Maintain continuing and change-driven training. No title, credential or elapsed time replaces task-specific competency evidence.