Sr. Manager, Manufacturing Quality

About this role

Use Your Power for Purpose Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.   What You Will Achieve Accountable for activities involved in the evaluation and review of clinical or commercial batch records, batch disposition, and review/approval of product/process related documents to determine if product specifications are met, ensuring that established sampling and statistical process control procedures are followed, identifying and reviewing deviations from established standards in the manufacturing and/or packaging of products, and reviewing and approving investigations and change control activities to ensure compliance with configuration management policies. The Manufacturing Quality Senior Manager provides strategic quality leadership for manufacturing operations and serves as a key quality authority at the site. This role bridges Manager level execution and Director level accountability by owning complex quality systems, regulatory significant decisions, and cross functional quality strategy execution.

The Senior Manager acts as a quality liaison between Manufacturing, Technical Operations, and Quality Leadership, ensuring inspection ready operations, sustainable compliance, and robust risk management. This role is accountable for governance of investigations, contamination control strategy, environmental monitoring programs, and continuous improvement initiatives that impact patient safety, product quality, and regulatory outcomes.   In this role, you will: • Acts as technical / functional expert providing leadership and direction to direct reports and other teams across own and related disciplines. • Identifies existing process/product improvements and develops innovative, advanced new concepts that improve work processes/products across own and related disciplines. • Set and manage high-complexity project objectives, leading people, technology, and financial resources; may lead by influence rather than direct authority. • Lead teams to implement strategic direction and influence senior management decisions. • Serve as senior quality authority for assigned manufacturing operations, providing oversight and regulatory judgment for high risk, high complexity activities. • Provide final quality input and approval for complex deviations, investigations, product impact assessments, and disposition decisions. • Conduct quality reviews, develop and implement global quality and compliance expectations, support audits and inspections, and encourage lean operations by reducing non-value-added activities. • Partner with leadership to achieve objectives and manage Pfizer direct reports to ensure performance aligns with divisional goals. • Interpret and apply FDA cGMP requirements (21 CFR 210/211), EU GMP Annex 1, and internal Pfizer standards to site operations in a risk based, inspection ready manner. • Act as a primary quality interface during regulatory inspections, internal audits, and third-party assessments. • Ensure consistent application of robust root cause methodology, appropriate scoping, and effective CAPA development. • Review and approve complex investigations to ensure clarity, regulatory defensibility, and sustainability of corrective actions. • Identify and address systemic trends through proactive quality improvements. • Provide leadership and strategic oversight of Environmental Monitoring (EM) programs, contamination control strategies, and aseptic behaviors. • Ensure EM trending, alert/action level responses, and investigations align with regulatory expectations and site risk profile. • Sponsor and lead contamination control and EM program improvements, including investigation reduction initiatives and digital trending enhancements. • Serve as the quality liaison between Manufacturing Operations, Engineering, Validation, Microbiology, and site leadership for complex issues. • Lead cross functional forums such as investigation triage, quality risk reviews, and escalation discussions. • Influence upstream decision making to integrate quality considerations into project design, change management, and operational strategy. • Resolve conflicts and drive alignment while maintaining compliance and patient focus. • Translate site performance data and trends into actionable improvement plans. • Mentor and coach Managers, Senior Quality Professionals, and Quality Operations colleagues. • Establish consistent standards for quality decision making and “what good looks like” across critical processes. • Assess talent needs, identify talent within the organization, and hold managers accountable for developing a diverse talent pipeline. • Contribute to succession planning and development of future quality leaders. • Maintain year-round inspection readiness through governance, self-identification of risk, and proactive remediation. • Ensure regulatory commitments and CAPAs are sustainable and aligned with Pfizer expectations. • Act as a trusted quality advisor to site leadership during high impact or ambiguous situations.  

Here Is What You Need (Minimum Requirements) • Applicant must have a bachelor's degree with at least 6+ years of experience; OR a master's degree with at least 5+ years of experience; OR a PhD with 1+ years of experience • Experience in GMP-regulated industries in Manufacturing Operations

• Demonstrated record of successful interaction with global regulatory and other internal and external auditing groups • Thorough understanding of the technical and commercial aspects of pharmaceutical API products • Excellent verbal and written communication skills • Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the

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