QA Operations Manager

Why Patients Need You

Everything we do every day is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible innovative and customer oriented. Whether you are involved in development maintenance compliance or analysis through research programs your contribution will directly impact patients.

What You Will Achieve

In your role you have the all-important task of providing Quality Assurance oversight to GMP manufacturing and testing operations for clinical drug substance intermediates and starting materials.

This includes quality oversight of technology transfer and disposition deliverables such as review of batch records investigations CAPAs SOPs test methods change controls and release of drug substance intermediates and starting materials (e.g. cell banks). In addition to general QA oversight you will be responsible for driving local implementation of electronic batch records establishing and maintaining governing procedures and providing global SME support as electronic batch records are deployed throughout PharmSci. You will be relied on to support globally across PharmSci partner lines and Pfizer Global Supply to align goals and support the implementation of effective quality system solutions. Your skills will help you collaborate and implement practices and gain efficiencies throughout quality procedures and R&D documentation.

As a Manager your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing important deliverables on time. Your innovative use of communication tools and techniques will make it easy to manage difficult issues and help in establishing consensus between teams.

It is your dedication and hard work that will make it possible for Pfizers customers and patients to receive the medicines they need when they need them.

How You Will Achieve It

• Represent BTxPharmSci at EBR Site Lead Meetings and offer quality insight for new technologies being developed/implemented

• Perform Quality Review and approve Master Template Records including built in properties

• Offer Quality support during manufacturing runs and advise on how to fix issues within electronic batch records to stay compliant

• Have a thorough understanding of Master Control and how it impacts site quality and compliance requirements

• Be the QA point of contact and SME for initial EBR implementations across multiple sites and business lines

• Participate in stake holder meetings within Pfizer and with Master Control to contribute ideas to new developments specific to business lines

• Have a thorough understanding of quality and compliance standards as it relates to Batch Records

• Help develop review and approve new batch records within Master Control that support new manufacturing processes

• Have a thorough understanding of pharmaceutical manufacturing to ensure batch records and Master Templates are compliant

• Participate in discussions and help make decisions of new features from Master Control to implement across BTxPharmSci

• Contribute to the completion of complex projects manage own time to meet agreed targets and develop plans for work activities on own projects within a team.

• Review and/or approve various GMP documents primarily batch records and investigations and including procedures change controls validation qualifications and CAPAs.

• Perform quality assurance disposition function for raw materials in-process solutions and/or production batches.

• Evaluate applicable corrective and preventive action responses to the audit findings for adequacy and timeliness.

• Participate on technology transfer teams reviewing and approving master batch records and related documentation.

• Support the site relative to a constant state of inspection readiness.

• Participate in audits relative to this role as needed.

• Make quality decisions to resolve moderately complex issues with minimal assistance from management.

• Recognize when an issue is beyond their sphere of influence and escalate immediately.

• Present to peers/management locally or electronically.

• Contribute to quality assurance management team initiatives and objectives.

• Provide review of equipment/instrument validation documentation and related calibration documentation as needed.

• Participate on special projects limited duration teams and local or global initiatives such as continuous improvement teams for Quality Assurance.

• Participate in quality risk management activities.

• Assist in the process of gathering interpreting and applying statisticalmethods to various Production/Quality related processes and communicate those through reports memos files and presentations.

• Assist in the review of area documentation and perform trend analysis on data controls and standards.

• Responsible for knowing understanding and acting in accordance with Pfizers values.

• Demonstrate strong interpersonal teamwork and collaboration skills.

Here Is What You Need (Minimum Requirements)

• Applicant must have a bachelors degree with at least 4 years ofexperience; OR a masters degree with at least 2 years of experience; OR a PhD with 0 years of experience; OR as associates degree with 8 years
  of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience

• Substantial experience in pharmaceutical manufacturing and quality control

• Strong understanding of Current Good Manufacturing Practices (cGMP) and handling compliance issues arising from cGMP deviations or product defects

• Strong critical thinking skills and a proactive approach

• Ability to collaborate effectively manage relationships and communicate well both in writing and verbally

• Advanced computer skills in MS Office applications and a good understanding of enterprise systems such as PDM Quality Tracking System Master Control Trackwise and Documentum platforms

Bonus Points If You Have (Preferred Requirements)

• Extensive experience in Quality Systems in pharmaceutical medical device or combination product industry

• Knowledge or exposure to data science

• Strong leadership and team management skills

• Ability to work under pressure and meet tight deadlines

• Ability to influence and negotiate with stakeholders

• Experience in conducting internal audits and supporting regulatory inspections

PHYSICAL/MENTAL REQUIREMENTS

Mental agility to handle a broad scope of different types of quality assurance work (e.g. reviewing documentation focus communication 1:1 and with larger groups). Ability to independently problem solve and make recommendations for solutions. Role is primarily office-sitting standing walking and bending. This may be inclusive of leading/participating in video conferences.

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

None

NO RELOCATION SUPPORT AVAILABLE*

Work Location Assignment:On Premise

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