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)

• Applicant must have a High School Diploma (or Equivalent) with 10 years of relevant experience; OR an Associate's degree with 8 years of experience; OR a Bachelor’s degree with at least 5 years of experience; OR a Master’s degree with more than 3 years of experience; OR a Ph.D. with 0+ years of experience. 

• Pharmaceutical manufacturing/Quality experience 

• Current Good Manufacturing Practices experience with compliance issues resulting from cGMP deviations or product defects, regulations as related to vendor management programs and other industry quality systems and processes 

•  Advanced computer skills in MS Office applications and good knowledge of enterprise systems 

• Expertise with investigation of complex technical issues.

Bonus Points If You Have (Preferred