QA Compliance Manager
The QA Compliance Manager is a senior contributor supporting compliance and auditing activities within Pharmaceutical Sciences Quality Assurance (PSQA). The candidate will ensure maintenance with current Board of Health (BoH) and industry regulations/expectations as applicable to biological clinical trial materials and governing quality systems. The QA Compliance Manager is responsible for coordination and execution of internal and external audits per applicable global procedures and will lead cross site efforts/projects in support of compliance for Pharmaceutical Sciences.
The QA Compliance Manager applies sound technical and quality knowledge to interpret and apply regulations/requirements across a broad range of cGMP activities, and provides sound guidance/direction to GMP functions. The QA Compliance Manager makes complex and routine decisions with minimal guidance from management.
This position requires a solid understanding of quality systems as they relate to the manufacturing, testing and packaging of biologic cell banking, API/drug substance, sterile drug product and medical devices. Experience with medical devices, vaccine, and cell/gene based therapies is strongly preferred.
The candidate shall possess the capabilities currently, or possess the capabilities to learn and expand their knowledge moving forward, of quality requirements governing biological clinical materials at different phases of the product lifecycle (i.e., IND through BLA). The candidate shall also possess the ability to navigate global systems and to identify and manage different levels of risk in support of good quality judgment against global systems and regulations, including advising the business on moderately complex quality issues.
Business travel may be required to other Pfizer locations as well as to alliance partners or contractors/suppliers/external laboratories used by Pfizer.
This position does not include the management of direct reports.
This position is based at the Andover, MA Pfizer location.
Responsible to develop, adhere to and execute against the internal and external audit schedule to meet procedural requirements.
Responsible for developing and supporting Inspection Readiness activities for audits and inspections, and ensuring a state of readiness for Pharmaceutical Sciences in Andover.
Executes internal and external audits to ensure compliance with current BOH expectations, including sound audit preparation, execution, and timely reporting and follow up on actionable items.
Contributes to the maintenance of the Pharmaceutical Sciences Global audit program in compliance with applicable Pfizer Quality Standards, as well as continuous improvement of the program.
Ensures ongoing presence within GMP manufacturing and testing areas to assist Pharmaceutical Sciences’ ability to maintain exemplary compliance.
Establishes her/himself as an SME for cGMP related compliance and acts as a resource to GMP functions as needed.
Collaborates across the network and industry to identify and replicate best practices for auditing and to maintain currency with latest BOH expectations.
Supports resolution/assessment for cross site observations through the established RONA program.
Possesses the ability to lead quality audits and host BoH inspections.
Supports audits and inspections regarding biologic and/or device platforms and associated quality systems.
Executes moderately complex tasks with minimal coaching.
Presents to peers/management/leadership locally or via WebEx.
Possesses experience with utilizing quality risk management principles.
Interprets, advises and executes against evolving regulations with respect to new focus areas such as Data Integrity and novel technologies and modalities such as bi-specifics, nanoparticles, vaccines and gene/cell based therapies.
Possesses the ability to understand complex global and pan-Pfizer work processes and systems, such as Pharm Sci/PSQA interactions with other Pfizer groups or external partners.
Advises on policies and procedures. Leads interpretation of GMPs for the functional areas.
Leads and/or participates on special projects, limited duration teams, and local or global initiatives such as continuous improvement teams for Pharmaceutical Sciences and PSQA.
Interprets and disseminates information regarding current industry and regulatory trends; advises customer groups on current industry standards and modifications to current systems required to meet these standards.
Conducts training in compliance and regulations.
Educational Requirements: BS with minimum of 12 years technical / scientific / Biopharmaceutical experience. MS with minimum of 10 years technical / scientific / Biopharmaceutical experience. PhD with minimum 7 years technical / scientific / pharmaceutical experience relevant work experience.
Minimum of 7 years of Biopharma industry experience that includes a broad understanding of Biopharmaceutical Sciences processes.
In addition, extensive knowledge of global GMP and regulatory requirements as related to the drug development process is required.
Team player with strong interpersonal, organizational, and communications skills are a must.
Additionally, the candidate must be self-motivated, engaged and able to perform moderately complex tasks independently.
Experience in Quality Assurance possessing strong quality culture is desirable.
Mental agility to handle a broad scope of different types of quality assurance work (i.e., reviewing documentation, conducting audits and hosting inspections, communicating one on one or with larger groups). Ability to independently problem-solve and make recommendations for solutions.
As this role can represent Pfizer potentially to third parties or BoH inspectors it is essential that the candidate has the ability to remain calm under pressure and is able to adjust and modify their style dependent upon the specific audit situation.
Role is primarily office-sitting, standing, walking and bending. This is inclusive of leading/participating in Webex.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Standard 40-hour work week.
Some travel required.
OTHER JOB DETAILS
Last Date to Apply for Job: 8/9/21
Eligible for Employee referral