Senior Associate External Supply Operations Quality (ESOQ)

Senior Associate External Supply Operations Quality (ES O Q )
Role Description:

• The Global External Quality Operations Mission is "to be a proactive partner, driving a science and risk-based compliant quality culture that is flexible, innovative, and customer oriented, maximizing the contribution of Quality Operations to Our Path Forward initiatives."

• External Supply Operations Quality (ES O Q) is committed to supporting Pfizer Global Supply (PGS) as an innovative and competitive advantage for Pfizer by assuring the quality of products manufactured and packaged by other companies (Contractors) for Pfizer.

• ES O Q is responsible for the Quality & Regulatory management of approximately 300 contract manufacturers, packagers, and supply partners globally.

Responsibilities :

• A ccountable for providing quality assurance management of key contractors for Pfizer and for assuring that the products supplied to our patients are manufactured & tested in accordance with c-GMPs, the registration file and any additional country specific requirements .

• Provide Quality Leadership and act as regulatory expert within the VSOT, advising of regulatory strategy and potential supply constraints if any.

• Assess the quality of external supplier's products, processes and related documents while ensuring the product specifications are met and quality systems are maintained .

• Support internal and external partners with auditing activities related to ESOQ activities, or activities at a portfolio of contractors -( RQA audits or regulatory inspections ) as applicable

• Support internal and external partners with Compliance Assessments to ensure current GMP/GDP adherence

• Support onboarding activities of new CMO's or product launches within the portfolio as applicable.

• Make product Quality decisions leveraging comprehensive knowledge of Quality/Manufacturing principles, prior work experience and concepts in other technical areas while ensuring compliance to global regulatory and Pfizer requirements.

• Influence quality decision making in line with industry and Pfizer requirements

• Partner with colleagues to develop and negotiate Quality Agreements.

• Initiate, review and approve regulatory changes through Pfizer enterprise system ( i.e PDM ) for changes initiated by or impacting ESOQ managed contractors.

• Provide support for the closure of the deficiency letters, CMC Commitments, Regulatory requests for Renewals, New Product registrations and Post approval variations.

• Main point of contact for Global Chemistry Manufacturing & Controls (GCMC) dept. or Local Regulatory Affairs in Pfizer Country Offices (Single market prods) for regulatory activities involving the ESOQ contractors.

• As the Regulatory Expert, participate in Virtual Site Operating Teams (VSOT) or similar meetings for ESOQ managed contractors and if needed, participate in Site Quality visits at the contractors.

• Support and Perform Lot Disposition for Biotech semi-finished and finished products (if applicable).

Qualifications:

• Minimally 5years of experience in GXP setting and/or Regulatory Affairs role (Pertinent Master's degree required ).

• Expertise in external suppliers/contractors, Change Management and Regulatory

• Advanced computer skills, MS Office and enterprise systems such as SAP, QTS, PDM, Documentum platforms

• Command of English language required and multi-lingual is a benefit

• Strong verbal and written communication including presentation skills

• Shows strong negotiation skills and is diplomatic in communication with internal and external customers

• Demonstrated ability to manage multiple projects and priorities

• Demonstrated ability to prioritize work, to act and work independently and to report items as required to Team leader

• Demonstrated excellent organization skills

• Demonstrated experience managing complex quality and compliance activities in a manufacturing plant or with a contractor

• Developing personal leadership to manage cross functional projects

• Developing ability to resolve conflicts

• Takes initiatives and is proactive, persistent

• Has a broad GMP and technical know-how to handle emerging issues

• Able to report remotely and deliver work independently

Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
School of Leaders
We, as Pfizer Turkey, make a difference with our visionary and pioneering approaches ranging from our concept of raising leaders through rotations, providing international career opportunities to creating a flexible, enjoyable work environment. There are no limits to what we can accomplish to touch lives here!
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let's start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Quality Assurance and Control