Validation 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 At Pfizer, you'll handle quality programs and processes to meet standards and guidelines. You will ensure quality assurance upkeep and link regulatory bodies with Commercial Quality and Distribution teams to define projects and assess changes affecting product licenses and GMP areas. Collaboration with Operations and Quality teams is key to establish compliant systems and SOPs. Implement aligned processes to support efficient commercial quality operations in line with business growth. As a manager, you'll guide operational teams, plan resource forecasts, and identify improvement areas in products, processes, or services. Leverage your expertise to advance new methodologies and lead team agreements. Your dedication will help Pfizer reach new milestones and support global patients. Responsible for knowing, understanding, role modeling, and ensuring others follow Pfizer's values and our OWNIT culture. How You Will Achieve It Proficiency is required in commercial quality, supplier quality, and manufacturing practices. Recognize opportunities, expert knowledge, best practices, and cost-saving possibilities. Provide guidance, lead/co-lead projects, manage own time to meet objectives, and plan resource requirements for projects across the division. Provide guidance on how to work with global regulatory agencies. Ensure global products requirements are reviewed and considered in existing Quality Management System (QMS) processes. Responsible for review, approval and final authorization of validation documentation (process, cleaning equipment, utilities, computer, and automation) and ensuring adherence to regulatory agency requirements, ICH guidelines, Pfizer standards, policies, and values. Manage projects and activities on deliverables ensuring accuracy, internal consistency, uniformity and compliance with regulatory commitments and expectations. Support audits team and cultivate relationship with Pfizer Audit/Inspection teams and recommend the reports that address needs. Assist with Board of Health audits in various capacities, including subject matter expert, auditor's scribe, and/or gatekeeper. Conduct and execute change control evaluations for modifications or introductions of materials, equipment, processes, and systems. Strong communication and presentation abilities, capable of quickly earning trust and establishing credibility within Quality & Compliance, Supply Chain, and Commercial departments. Comfortable with ambiguity in complicated settings. Simplifies complexity for others to understand easily. Strong relationship development, conflict resolution, and team building instincts, with the ability to build partnerships both internally and externally. Engages in open and honest communications. Participate in complex investigations of product/facility deviations and investigations including root cause analysis, and approval of investigation reports. Makes decisions that may impact project progression and timelines. Demonstrates sound judgment on decisions that may involve complex technical issues. Qualifications Must-Have 8 -10 years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field Demonstrated organizational and project management skills Demonstrated strength in analytical skills and attention to detail Good understanding of relevant regulatory and audit frameworks that apply to the biopharmaceutical operations Able to take action on quality and compliance metrics and trends Ability to manage multiple complex projects and has business acumen Excellent interpersonal effectiveness and written and verbal communication skills Nice-to-Have Master's degree A varied business background, particularly in quality assurance, validation (CSV, Equipment, Process, Facilities), regulatory affairs, and compliance. Expertise is needed in commercial quality, supplier quality, as well as in manufacturing and distribution practices. Experience in aseptic processes and operational knowledge Knowledge of training design and tools, and experience in applying training methodology PHYSICAL/MENTAL REQUIREMENTS Lifting, sitting, standing, walking, bending Relocation support available Work Location Assignment: On Premise Last day to apply: November 11th, 2024 The annual base salary for this position ranges from $93,500.00 to $155,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 12.5% 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 | (). 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 Act Pfizer 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 Eligibility Pfizer 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 LI-PFE

Created: 2024-11-01