New Products and Business Quality Lead

Use Your Power for Purpose

Every day Pfizers 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 toGQO ESOQ External SupplyPharmSci PGS and keycustomers and stakeholders in the evaluation selection development qualificationand integration of new suppliers partnersproductsand Leadis responsible forassuring commercial readinessof allnew suppliers/ includes qualifying new suppliers and partners (including negotiation and approval ofQuality Agreements) providing Quality support for new products (Co-development teams) PNS initiatives (technical transfers) leading or participating instrategicESOQ and GCO projectsand conducting third party assessments (Sterility Assurance Quality Culture Data Integrity Deviation Packaging etc.). This position also requiressolid understanding of compliance regulations knowledge of Quality by Design(QbD)conceptsand Quality Systems as they relate todevelopment manufacturingpackagingand release of small and large molecules including vaccines devices andAPIs.

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 collaborativelywith stakeholders to ensure adherence to theprocess for Evaluation and Selection of new Suppliers and Partners by leading/supportingqualificationand onboarding activities.

• Provide support to PSQAOperationsteams by:

  • Collaborating with BDQ Quality OpsBTx&PSSM portfolio leads on approved BD initiativesto enable successful transfer of informationdocumentationand PoCs to working teams ( Team or Co-Development Team).

  • In collaboration withBTx& PSSMtechnology teams and relevant SMEsestablishrequirements for quality systems for new manufacturingdeviceor diagnosticprocess.

• Provides support to theESOQ operations teams by:

  • Ensuring a seamless transitioninto commercial and operational oversight of all new suppliers/partners.

  • Conducting third party assessments such asSterility Assurance QualityCulture DataIntegrity DeviationPackagingetc.

  • Engaging as needed in significantissueresolution and remediation.

  • Supportsexit strategiesofthird parties.

• Partners withPharmSciandGTE to support Co-Development initiatives and new product launchesensuring commercial readiness of both supplier(s) and product(s).

• Partners with both GTE and EStosupporttechnology transfers involving third parties managed ormanagedby ESOQ.

• Participates in PGS site divestiture teams and provides Quality support to ensureappropriate integrationofthe divested site into the External Supply network.

• Negotiates Quality Agreements with allnew third parties.

• Supports andparticipatesin 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 ofBachelors degree in Biology Cell Biology Chemical EngineeringBiochemistry Microbiology ChemistryPharmacyor related science with a minimum of 10-15 years experience in the pharmaceutical industry including10 years of relevant QA/QC/Mfgexperience.

• Broad understandingofPfizerPharmaceutical Sciences Biological Development process.

• Knowledgeof parenteral dosage forms combination products and devices is desired.

• Experience inmanaging external suppliers/partners/contract laboratories isrequired.

• Demonstratedability 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 qualitysystemsas they relate todevelopmentof product.

• Experiencesupporting or leading Quality diligence assessments and developing/managing remediationplans.

• Command of English language isrequired and multi-lingual skills is and verbal communication skillsisrequired.

• Experience with Informational Systemsand Databases used by Quality Assurance isrequired.

• Demonstratedability tonegotiateand collaborate with individuals and groups at multiple levels across theorganizationincluding senior leadership of various functional lines across PGS.

• Demonstrated relationship building and negotiation skills particularly in developing relationships withnew customers and business partners.

• Thorough knowledge of pharmaceuticalcGMPsand global governmental regulations including US FDA and EMA.

• Demonstrated personal leadership to work in virtual teams and cross functional projects/initiatives.

• Isdiplomaticclearand succinct in communication with internal andexternalsstakeholders.

• Demonstrated experience managing complex quality andcompliance activities.

• Self-motivator with proven ability to lead independently.

• Takesinitiatives and is proactive/persistent.

• Strong organizationaland planning skills and a high sense of urgency.

• Demonstrated technicalknow-how.

• Proven leadership/facilitation skills and able to involve several levels of an organization to successfully meetobjectives.

Bonus Points If You Have (Preferred Requirements)

• Masters 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 multipleprojects and complex suppliers/partners.

• Candidatedemonstratesa breadth of diverse leadership experiences and capabilitiesincluding ability to influence and collaborate with peersdevelopment and coaching of othersoversightand guidance of other colleagues to achieve meaningful outcomes and create business impact.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.