Biotherapeutics (BTx) Pharmaceutical Science (PharmSci) Portfolio Quality Lead

The Biotherapeutics (BTx) Pharmaceutical Science (PharmSci) Portfolio Quality Lead is a multi-site, global leadership role with responsibility for setting and implementing Quality strategy and operational leadership for the BTx PharmSci portfolio throughout all stages of clinical development. The role, in partnership with the BTx PharmSci Quality Operation Lead, has Quality oversight for the development, manufacturing, testing, disposition, and launch readiness of investigational medicinal product across Pfizer’s biologics portfolio. The role supports a deep and complex pipeline of large molecules and highly flexible manufacturing processes throughout clinical development. The role is responsible for overseeing and managing comprehensive quality project or portfolio wide strategies to compliantly support accelerated timelines for clinical programs. Both a strong scientific background and quality risk management skills are required to support molecules under development where the basic science, manufacturing, and testing methods are fluid and not yet validated. The position requires strong adaptability to support the development of new drug modalities or advanced methods of manufacturing under development. The position reports to VP PharmSci Operations Quality (PSOQ) and includes working with the PSOQ Leadership Team (PSOQ LT) to set strategy, organizational structure, talent management, and direction of the PSOQ organization across the global network. The position represents Quality on senior Pfizer portfolio governance bodies overseeing biologic development. ROLE RESPONSIBILITIES Responsible for setting and implementing global quality strategy and systems for the biologics portfolio throughout the development lifecycle to commercialization including: Gene therapy, traditional vaccines, mRNA vaccines, monoclonal antibodies, bi- and tri-specifics and antibody drug conjugates Leads a global or multi-site team responsible for providing quality leadership over the PSPT/CDT teams and ensures alignment across various internal and external Quality groups (e.g., PGS Site Quality, External Supply Quality, external vendor Quality organizations). as appropriate. This position is responsible for leading leaders. Collaborate with quality, business lines, and therapeutic area leaders across the portfolio and plant networks to deliver high quality clinical materials and ensure a smooth transition to Pfizer Global Supply (PGS) manufacturing, vendors, and testing sites. Provide accountable quality leadership over the project teams/portfolio to assure alignment across various assets and ensure effective implementation of quality strategies, quality governance and compliance performance. Provide Quality oversight to acquired entities or assets and integration into Pfizer Quality Systems including management/execution of Quality Integration Plan. Develop control and release strategies for projects in collaboration with business lines and GCMC. Review and approve significant investigations, including MIRs and LIRs, issue notification to management/issue escalations, lead and approve AQRTs. With VP PSOQ, leads Area Quality Review Teams to adjudicate potential product quality-related issues within impacting biologic clinical programs. BASIC QUALIFICATIONS Required: BS in Chemistry, Chemical Engineering, Biology, Pharmaceutical Sciences, Pharmacy or other appropriate science, or equivalent. Candidate should possess a minimum of 15 years of Pharmaceutical Industry experience and a very broad understanding of Pfizer Pharmaceutical Science Development process. A minimum of 10 years in a Quality Assurance/Quality Control function is desired. Excellent communication skills including use of Informational Systems and Databases used by Quality Assurance is required. Must be capable of strategic decision-making and critical, risk-based thinking. Proven track record of leading organizations and ability to lead colleagues both directly and within matrix organizations, interact with colleagues at all levels of the organization including senior internal colleagues and external contacts Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact. PHYSICAL/MENTAL REQUIREMENTS Mental agility to handle strategic decision-making across different divisions of the organization (i.e., in collaboration with Quality Site leaders across the network, Portfolio Leads, including above site leaders). Able to manage a large scope of responsibilities, work well under pressure and under frequently changing priorities Additional Position Detail Last Date to Apply - May 25, 2023 Position can be remote Work Location Assignment: Flexible Relocation assistance may be available Relocation assistance may be available based on business needs and/or eligibility. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. Quality Assurance and Control #LI-PFE Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.