MQA Technical Lead

Why Patients Need YouEverything 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 AchieveAt Pfizer, you will play a critical role in Quality Operations. The Manufacturing Quality Assurance (MQA) Technical Lead provides leadership to a team of Associates who are responsible for Quality Assurance on the floor activities related to any of the modalities manufactured at Sanford. The MQA Technical lead will evaluate and review Pfizer’s clinical and commercial batches to ensure compliance with regulatory requirements, quality agreement requirements, and Pfizer expectations. They will provide guidance to operational teams and quality oversight of manufacturing, housekeeping, and overall GMP compliance. The Technical Lead not only leads the team but also takes part in the execution of related functions.You will ensure adherence to regulatory expectations, safety, and GxP (i.e., Current Good Manufacturing and Documentation Practices).How You Will Achieve ItIn this role your responsibilities will be :• Recruit, onboard, train and develop colleagues under his supervision.• Assess manufacturing operations/documentation to ensure proper execution and adherence to Procedures, Regulatory requirements, Safety, Quality Agreement requirements, and Pfizer Quality Standards (PQS) expectations.• Facilitate internal & external meetings and provide training/presentations/updates/report-out to QA and Manufacturing colleagues on a regular basis.• Lead & identifies Continuous Improvements (CI) initiatives to improve safety and processes and successfully utilize IMEX tools and the “one best way” philosophy.• Represent QA in cross-departmental/cross-site meetings. Aid in resolving and provide guidance/path-forward. Independently makes decisions with minimal assistance from QA management. Escalate issues timely.• Provide guidance/coaching/training to less experienced QA and Manufacturing colleagues.• Participate in internal Good Manufacturing Practices {also cGMP} audits, support regulatory inspections or corporate audit activities.• Assist with other tasks as needed such as Internal Audits/Assessments, Gap/risk assessments, Regulatory Inspection Readiness.• Manage own time to meet objectives, plan of record deliverables, and project milestones.• Support the development of quality strategic initiatives based on risk and business needs, in close collaboration with key stakeholders. Ensures Real time review of batch documentation and other manufacturing documentation analyzing for errors, corrections, and compliance• Monitor and Perform housekeeping and GMP walkthroughs of facility• Triage events and initiate deviations as needed. Assist with driving effective management of quality issues and corrective action plans that may involve complex quality and technical issues.• Provide quality leadership to cross functional teams to meet and exceed timelines• Execute or review room and line clearances• Makes quality decision in real time according to regulations ICH Q7 and 21CFR211 and internal procedures• Ensures QA support to Manufacturing Operations to include the following tasks: Real time batch record, logbook, and compound record review, acceptance Quality Limit Testing and Drug Product Visual Inspections, Media Fills, Smoke Studies, Change Overs, Line Clearance (mAbs), Logbook Review (mAbs), Aseptic Observations.QualificationsMust-Have• Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience OR an Associate's degree with 8 years of experience OR a Bachelor's with at least 5 years of experience OR Master's Degree with more than 3 years of experience, OR a PhD with 0+ years of experience.• Experience in manufacturing, quality in the biotech or pharmaceutical industry.• Previous management experience• Working knowledge in a biopharmaceutical/pharmaceutical cGMP environment.• Knowledge of electronic systems such as Veeva, Trackwise, Documentum/PDOCs, SAP, LIMS, Microsoft Office.Nice-to-Have• Master’s degree and relevant pharmaceutical experience.• Experience authoring, review, etc. of procedures or training materials.• Experience with aseptic practices, investigations, manufacturing support and batch release activities.• Preferred experience with leading a team.Physical/Mental Requirements:• Good judgment and correct decision making based on company procedures/standards, technical experience, and industry guidance / regulatory requirements.• Collaboration skills and the ability to independently engage with a wide range of co-workers, customers, and management to gather the input and background knowledge needed to complete assignments.• Requires working on shop floor and office setting Aseptic Gowning into manufacturing areas.• Computer usage would be typical• Ability to stand for 2 to 3 hours at a time Visual inspection of particulates for more than three (3) hours a session.• Evaluate complex mathematical calculations. Walk long distancesNon-Standard Work Schedule, Travel, or Environment Requirements:• Remaining in a controlled environment for more than three (3) hours.• This is 12 hours shift position. Night shift (Sun-Wed 7PM-7AM). Occasional overtime is required.Other Job Details:• Last day to Apply: November 25th• Eligible for Relocation Assistance: No• Work Location Assignment: On SiteThe annual base salary for this position ranges from $99 900,00 to $166 500,00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 15,0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.Relocation assistance may be available based on business needs and/or eligibility.Sunshine ActPfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.EEO & Employment EligibilityPfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.Quality Assurance and Control