Senior Manager Medical Devices and Combination Products Quality Operations

About the position Responsibilities • Oversees and ensures compliance with SOP’s, quality standards (e.g. 21 CFR 820, ISO 13485, IEC 62366, IEC 62304, ISO 14971) and regulatory requirements, including conducting audits, identifying areas for improvement, and implementing corrective actions. • Routinely provides guidance and interpretation of SOP’s and standards within PharmSci and with external partners. • Act as the quality assurance and medical device quality lead supporting MDCPs through reviews and approvals of all MDCP lifecycle documentation including design controls, risk management, quality management systems, change controls, vendor management, and complaints. • Monitor changes to global regulations and ensure policies and procedures reflect applicable changes, implements quality system best practices, and communicates company-wide policies on quality system effectively. • Identifies, leads development of, and participates in implementation of new processes/programs for quality improvement initiatives with the MDCP space. • Proactively seeks global alignment / interpretation in application of policy / procedure. • MDCP Quality Assurance oversight of facility, utilities, equipment, computer system validations and change controls. • Support Management Review & Quality Councils as required. • Has technical and quality knowledge on later phase product life cycle strategies (e.g. design verification, design validation, process validation, ICH stability, etc.). Leads and advises as needed. • Expert in quality investigation techniques and leads complex quality investigations and develops QA decisions. • Actively contributes to PSQRT/AQRT. • Creates, develops, and delivers training courses; performs review of training effectiveness, identifies trends, and develops actions to remediate compliance issues as required. • Evaluates highly complex quality issues on projects or with vendors and provides suggested issue resolutions. • Recognized as a coach, mentor, and technical expert; participates as an external influencer at conferences or standard committees. Requirements • Applicant must have a bachelor's degree with at least 6 years of experience; OR a master's degree with at least 5 years of experience; OR a PhD with 1+ years of experience • Thorough understanding and application of one of the following: 1) cGMP and current good manufacturing practices in a pharmaceutical environment, 2) 21 CFR 820, Rule 21 CFR “4” current good manufacturing requirements for Combination Products, or 3) medical devices and/or combination products including ISO 13485 & ISO 14971 • Experience working in multi-disciplinary teams as well as working independently in ambiguous situations/assignments, gathering input from colleagues and management to address issues • Demonstrated influencing and negotiating skills. • High awareness of personal limits and a willingness to proactively consult others to ensure quality of judgement • Strong leadership, negotiation, interpersonal, communication, and facilitation skills • Strong analytical and computer skills are required. Nice-to-haves • The combination of strong pharmaceutical and / or medical device development experience preferred • Thorough understanding and application of cGMP specifically 21 CFR 820, Rule 21 CFR “4” current good manufacturing requirements for Combination Products and the principles and concepts of relevant quality processes and systems • Extensive experience in risk management and design control of medical devices, combination products from concept through launch, or pharmaceutical manufacturing operations in a GMP environment • Proven ability to succeed in a fast-paced, challenging, and complex environment • Proven ability to mentor engineers • Experience interacting with FDA investigators and other regulatory agencies. • Knowledge and application of device root cause analysis methodology and device CAPA requirements. • Experience in change management (pre and post launch) of either medical devices or medical device combination products. • ISO 13485 Lead Auditor Certification Benefits • participation in Pfizer’s Global Performance Plan with a bonus target of 17.5% of the base salary and eligibility to participate in our share based long term incentive program • 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 • health benefits to include medical, prescription drug, dental and vision coverage Apply tot his job