QA Manager, Investigation Review

Use Your Power for Purpose

Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are involved in development, maintenance, compliance, or analysis through research programs, your contribution directly impacts patients.

What You Will Achieve

You will be a member of Pfizer's dedicated and highly effective quality assurance team. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations to ensure compliance with configuration management policies.

In this role, you will :

• Have sufficiently broad depth of knowledge of GXPs to be a key contributor or may be able to lead continuous improvement to a process or improve business efficiencies.
• Can identify and implement new processes and programs for quality improvement.
• Contributes to the interpretation of cGXPs for the commercial and clinical environment.
• Independently review working instructions / global procedures for technical content across multiple subject areas, with reference to applicable GXPs and regulatory expectations making value-added comments. Interfaces with other parts of the organization such as Pfizer research and development groups. Able to work outside immediate subject area, supporting a wider range of customers of differing subject areas and locations.
• Able to resolve complex issues with minimal assistance from management. Represents Quality Assurance in cross-departmental / cross-site / cross-network meetings / summits.
• Reviews trending reports and influences / agrees actions with key stakeholders.
• Provide guidance / coaching to less experienced colleagues.
• Interprets and understands complex data and forms conclusions and next steps based on findings with minimal assistance from management.
• Provides interpretation of data and reports.
• Advises on more complex policy and procedures.
• Makes decisions that may involve complex quality and technical issues.
• Expertise with investigation of complex technical issues and able to independently handle investigations across cross-functional work areas.
• Coach / mentor other colleagues during the investigation process.
• Collaborates / independently engages with a wide range of co-workers, customers and management within the OpU to gather the input and background knowledge needed to complete assignments.
• Anticipates issues and elevates them to appropriate management attention immediately.
• Demonstrates sound judgment on decisions that may involve technical issues.
• Able to assess internal and external compliance with applicable regulations.
• Trains colleagues on workgroup practices within area of expertise.
• Proactively and independently applies departmental best practices to work assignments.
• Able to recognize when such a multi-disciplinary discussion / issue is beyond their sphere of influence and escalates accordingly.
• Routinely demonstrate a good practice of technical exchange and open communication with team members. Participates in and may take a lead in decision making process.
• Team Involvement : Assigned as the Quality member of the project team empowered to speak for the Quality organization to other areas. Provides strategic input to accomplish team objectives. Established interpersonal skills (negotiation, managing conflict) to influence the team.
• Manage workload to meet established timelines.

Here Is What You Need (Minimum Requirements)

Bonus Points If You Have (Preferred Requirements)

Physical / Mental Requirements

Non-Standard Work Schedule, Travel, or Environment Requirements

Other Job Details

The annual base salary for this position ranges from $96,300.00 to $160,500.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver / parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage.