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Use Your Power for Purpose This position will oversee the Quality Control Laboratory in Rochester, MI. The Rochester Quality Control Laboratory performs: Assay, Viscosity, Breakloose & Extrusion, Sterility, Gas chromatography, pH, LOD, Bacterial Endotoxin, Karl Fischer, and multiple other analytical technologies used to determine quality attributes for Rochester manufactured Drug Products. The selected candidate will lead the laboratory to meet defined quality standards and QO objectives. Ensures cost effective activities/programs are implemented in compliance with regulatory standards, company policies, practices, and processes. Fosters teamwork and colleague development, as well as change management, within the laboratory and department. Provides guidance and coaching to QO colleagues and provides direction/approval of activities and decisions. Cultivates and reinforces appropriate group values, norms, and behaviors. Provides oversight to individuals and team on personal development, performance, and quality related issues. Writes and delivers performance reviews and oversees colleague development. Provides oversight of department ensuring proper use of assets, budget, and personnel. What you Will Achieve • Review and approve cGMP documentation to assure compliance with regulatory requirements. • Assess deviation impacts and resolve to prevent future occurrences. • Review and approve cGMP Changes in accordance with regulatory requirements. • Review and approve training to assure cGMP requirements are met. • Manage resources (people and assets) to meet work team goals. • Support a continuous improvement culture where individuals can thrive in change. • Thoroughly evaluate lab investigations, deviations, and associated corrective/preventive actions to ensure they are handled appropriately and documented effectively as they relate to the testing of raw materials, in-process samples, and final products. • Assures adherence to data integrity initiatives. • As a Subject Matter Expert (SME), represents the lab unit or the entire lab organization on high complexity projects and project teams both within and outside of QO. • Supports and may lead implementation of various elements of IMEx. Here Is What You Need (Minimum Requirements) Applicant must have a bachelor's degree with at least 4 years of experience; OR a master's degree with at least 2 years of experience; OR a PhD with 0+ years of experience; OR as associate's degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience Previous experience with leading colleagues and/or projects is required. The candidate must have excellent verbal and written communication skills, with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups. The candidate must have demonstrated proficiency in organizational and project management skills and must be able to balance multiple priorities. Bonus Points If You Have (Preferred Requirements) The candidate should have experience in multiple of the following areas: cGMP, Regulatory, deviation investigations, drug product lot release, analytical method transfer/validation, process validation, laboratory testing, and laboratory investigations. PHYSICAL/MENTAL REQUIREMENTS Laboratory and office work require walking, standing, and sitting throughout a shift. The job has minimal lifting but may have extensive sitting and walking time. The ability to concentrate for long periods of time is necessary. This is a penicillin manufacturing facility. All candidates applying must NOT be allergic to penicillin. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Non- Standard work schedule at times maybe required to support product release, including weekend, second shift, night shift work / call for process decisions. Minimal travel for training/seminars. Relocation support available Work Location Assignment: On Premise The annual base salary for this position ranges from $102,900.00 to $171,500.00. 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 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. Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned. Quality Assurance and Control Pfizer careers are like no other. In our culture of individual ownership, we believe in our ability to improve future healthcare, and potential to transform millions of lives. We’re looking for new talent to join our global community, to unearth new innovative therapies that make the world a healthier place.