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.
Actively contributes as part of ESOQ T2 structure to provide Quality support to GQO, ESOQ, External Supply, PharmSci, PGS and key customers and stakeholders in the evaluation, selection, development qualification and integration of new suppliers, partners, products and contractors. Quality Lead is responsible for assuring commercial readiness of all new suppliers/partners. This includes qualifying new suppliers and partners (including negotiation and approval of Quality Agreements), providing Quality support for new products (Co-development teams), PNS initiatives (technical transfers), leading or participating in strategic ESOQ and GCO projects, and conducting third party assessments (Sterility Assurance, Quality Culture, Data Integrity, Deviation, Packaging etc.). This position also requires solid understanding of compliance regulations, knowledge of Quality by Design (QbD) concepts and Quality Systems as they relate to development, manufacturing, packaging and release of small and large molecules including vaccines, devices and API’s.
What You Will Achieve
In this role, you will:
Leads and conducts Quality Due diligence assessments of potential third parties in support of network development initiatives and contractor selections.
Works collaboratively with stakeholders to ensure adherence to the process for Evaluation and Selection of new Suppliers and Partners by leading/supporting qualification and onboarding activities.
Provide support to PSQA Operations teams by:
- Collaborating with BDQ Quality Ops, BTx & PSSM portfolio leads on approved BD initiatives to enable successful transfer of information, documentation and PoC’s to working teams (e.g., PharmSci Project Team or Co-Development Team).
- In collaboration with BTx & PSSM technology teams and relevant SMEs, establish requirements for quality systems for new manufacturing, device or diagnostic process.
Provides support to the ESOQ operations teams by:
- Ensuring a seamless transition into commercial and operational oversight of all new suppliers/partners.
- Conducting third party assessments such as Sterility Assurance, Quality Culture, Data Integrity, Deviation, Packaging etc.
- Engaging, as needed, in significant issue resolution and remediation.
- Supports exit strategies of third parties.
Partners with PharmSci and GTE to support Co-Development initiatives and new product launches ensuring commercial readiness of both supplier(s) and product(s).
Partners with both GTE and ES to support technology transfers involving third parties managed or managed by ESOQ.
Participates in PGS site divestiture teams and provides Quality support to ensure appropriate integration of the divested site into the External Supply network.
Negotiates Quality Agreements with all new third parties.
Supports and participates in cross functional limited duration teams (LDTs) where applicable.
Lead and/or support quality system improvements to NPB process
**Here Is What You Need **(Minimum Requirements)
A minimum of Bachelor’s degree in Biology, Cell Biology, Chemical Engineering, Biochemistry, Microbiology, Chemistry, Pharmacy or related science with a minimum of 10-15 years’ experience in the pharmaceutical industry including 10 years of relevant QA/QC/Mfg experience.
Broad understanding of Pfizer Pharmaceutical Sciences Biological Development process.
Knowledge of parenteral dosage forms, combination products and devices is desired.
Experience in managing external suppliers/partners/contract laboratories is required.
Demonstrated ability to manage multiple projects and lead cross functional projects.
Is a strategic thinker.
Excellent Quality decision making skills.
Knowledge of Quality by Design (QbD) concepts and quality systems as they relate to development of product.
Experience supporting or leading Quality diligence assessments and developing/managing remediation plans.
Command of English language is required, and multi-lingual skills is beneficial. Comprehensive, demonstrated written and verbal communication skills is required.
Experience with Informational Systems and Databases used by Quality Assurance is required.
Demonstrated ability to negotiate and collaborate with individuals and groups at multiple levels across the organization including senior leadership of various functional lines across PGS.
Demonstrated relationship building and negotiation skills, particularly in developing relationships with new customers and business partners.
Thorough knowledge of pharmaceutical cGMPs and global governmental regulations, including US FDA and EMA.
Demonstrated personal leadership to work in virtual teams and cross functional projects/initiatives.
Is diplomatic, clear and succinct in communication with internal and externals stakeholders.
Demonstrated experience managing complex quality and compliance activities.
Self-motivator with proven ability to lead independently.
Takes initiatives and is proactive/persistent.
Strong organizational and planning skills and a high sense of urgency.
Demonstrated technical know-how.
Proven leadership/facilitation skills and able to involve several levels of an organization to successfully meet objectives.
**Bonus Points If You Have **(Preferred Requirements)
Master’s degree and 15+ years of relevant pharmaceutical experience.
Demonstrated experience in aseptic manufacturing and other pharmaceutical activities (API, DP, Biotech, Oral Solid Dosage) applicable to the role.
Demonstrated ability to manage multiple projects and complex suppliers/partners.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including ability to influence and collaborate with peers, development and coaching of others, oversight and guidance of other colleagues to achieve meaningful outcomes and create business impact.
Work Location Assignment: Hybrid
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Quality Assurance and Control