ESOQ Contractor Quality & Regulatory Manager
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Job Summary
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 (ESOQ) 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.
ESOQ is responsible for the Quality & Regulatory management of approximately 300 contract manufacturers packagers and supply partners globally.
Responsibilities:
The ESOQ Manager holds overall accountability for assigned CMOs with primary responsibility for quality oversight (approximately 80%) and secondary responsibility for regulatory oversight (approximately 20%) across operational activities.
The ESOQ Manager is accountable 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.
This is highly independent position operating with minimal supervision interacting with high levels of management both at contract manufacturers and within Pfizer.
(S)he will operate as spokesperson for ESOQ and will focus on developing relationships independently negotiating developing and communicating Pfizer quality requirements with contract manufacturers.
ESOQ Manager will have significant interactions with many internal business and manufacturing organizations (e.g. External Supply Regulatory Technical Support Quality PGS sites and R&D) and will lead virtually-based cross functional teams.
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) dpt or Local Regulatory Affairs in Pfizer Country Offices (Single market prods) for the regulatory activities involving the ESOQ contractors.
As the Quality & Regulatory Expert participate in Virtual Site Operating Teams (VSOT) or similar meeting 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 BA/BS Science Engineering or related technical discipline with at least 7 years in a GXP setting and/or Regulatory Affairs role
At least 4 years of Product Quality Assurance experience in a GMP manufacturing experience would be an asset.
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
Up to 20% travel may be required
Work Location Assignment:Hybrid
Purpose
Breakthroughs that change patients lives... At Pfizer we are apatient 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.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
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 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 iscommitted to celebratingthisin all itsforms 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.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
Required Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Erfahren Sie mehr über uns als forschendes und produzierendes Pharmaunternehmen: Von unserem Beitrag zum medizinischen Fortschritt bis zur nachhaltigen Produktion.
