Pfizer Centre One and Alliance Quality Sr Manager

Use Your Power for Purpose

The Pfizer Centre One (PC1) & Alliance Quality Sr Manager is responsible for providing quality support for the PC1 business conducted within the internal site network and / or through the external supply network as addition the team also provides support for alliance partnerships (third party companies with a shared interest in a product / products.

The position provides direction and support to internal stakeholders to ensure appropriate quality and compliance related decision making is conducted in compliance to Pfizers contractual or quality agreement obligations to contract givers and alliance partners.

The PC1 / Alliance Partnership Quality (Sr Manager) will play a key role in managing relationships with internal and external partners.

The role actively contributes as part of the ESOQ and PC1 T2 and T3 levels to support Quality related topics arising from the internal network or customer/ partner escalations.

What You Will Achieve

• Provide expert input and guidance to the internal site / external supply organisations / PC1 operations team in support of PC1 activities at those sites to ensure appropriate quality and compliance related decision making.

• Responsible for managing business critical and complex relationships with alliance partners to ensure efficient sharing of required information to facilitate the business.

• Support onboarding of new PGS Sites / External Supply within the PC1 Model/Framework

• Serve as subject matter expert for negotiations and revision of PC1 or alliance partner quality agreements ensuring Pfizers needs are accomodated. (Role may act as lead in Quality agreement negotiations where applicable)

• Provide guidance to internal stakeholders on the execution of and interpretation of quality agreement / supply agreement requirements as they pertain to PC1 activities or partner alliances where applicable.

• Manage performance with internal stake holders. This includes ensuring an effective governance structure within the Quality organisation to ensure that any required escalations are communicated via the internal and PC1 QO Imex tiering as applicable.

• Provide support to the network ensuring that partner obligations to Pfizer are sustained (i.e. that appropriate decisions and endorsements are provided on time etc).

• Serve as the point of contact for partnership impacting changes interfacing with partnership technical and quality groups as well as internal SMEs during change planning and change control activities.

• Lead initiatives to simplify and improve processes ensuring efficiency and alignment with business needs

• Ensuring compliance with cGMPs / and partner expectations as outlined in the governing agreements.

• Serves as Quality Lead on behalf of PGS Quality to strategic cross site projects with External Customers / Alliance partners

• Build and maintain strong relationships across partnership management and internal governance teams to assure quality expectations are aligned and support joint goals.

• Create and implement clear and timely action plans for issue resolution including escalation and communication to external customers / partners.

• Enable quality improvement / simplification initiatives to be established and implemented where required both with internal and external parties.

• Facilitate and coordinate internal forums to foster best practices and collaboration on common issues across the PC1 network.

• Support escalation activities and evaluations ensuring business and Quality requirements are met by both Pfizer and alliance partners with respect to QAAs and scope of responsibility.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelors degree with at least 6 years of experience; OR a masters degree with at least 5 years of experience; OR a PhD with 1 years of experience

• Experience in the pharmaceutical industry including roles that provided strong knowledge of GMP regulations and leading improvement initiatives

• Strong knowledge of quality and manufacturing operations

• Experience with external suppliers/contractors / alliance partners.

• Experience with core quality systems (including change control)

• Strong analytical and strategic skills with experiencing solving complex and unique problems

• Well-developed interpersonal skills with ability to work effectively across all levels of the organization

• Knowledge of Integrated Manufacturing Excellence (IMEx) or other lean manufacturing approaches

• Experience in leading/influencing internal and external stakeholders

• Experience in managing projects that require critical thinking collaborative approaches; innovation; strong analytical skills; ability to understand business issues and processes

• Strong analytical skills to assess information draw conclusions and recommend improvements

• Excellent communications skills both written and verbal to ensure clear information sharing between internal and external parties.

• Working independently and operating with minimal supervision interacting with high levels of management both internal to and external to Pfizer.

• Supporting ESOQ leadership on other tasks as required

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

• Up to 15% travel may be required

Work Location Assignment: Hybrid

Relocation assistance may be available based on business needs and/or eligibility.