Pfizer QO Regional Leader Sterile Injectables in Kalamazoo, Michigan
Reporting to the VP Quality Operations, Sterile Injectables US/EU, the Quality Operations Regional Leader, Sterile Injectables provides strategic and tactical leadership to the site quality organizations for three global aseptic manufacturing sites:
MMT St. Louis, US
The Quality Operations Regional Leader, Sterile Injectables ensures that Pfizer Quality Standards and cGMP requirements for manufacture of aseptic products are implemented and consistently followed.
The position will be a member of the Sterile Injectables US/EU Quality Leadership Team, and will be responsible for actively developing and contributing to network initiatives
General Scope of Responsibilities:
Provide strategic and tactical leadership to site QO units in 3 sterile injectable (SI) sites in US on all matters related to quality and cGMP compliance. Ensure consistency in achieving product quality and cGMP compliance across multiple manufacturing sites and global markets. Ensure that Pfizer Quality Standards and relevant drug substance/finished drug product requirements for manufacture of Aseptic products are implemented and consistently followed to establish site cGMP compliance. Ensure efficient and effective resolution of critical product quality/cGMP compliance issues. Provide support and guidance for major investigations and product quality and cGMP compliance issues as they occur. Work closely with the SI US/EU Operating Unit QO Leader to make decisions on SI site quality and cGMP compliance issues. Provides facilitation for key quality issues in preparation for AQRT's. Provide support to sites where necessary for regulatory inspections (planning, execution and closeout) including support in preparation of responses to findings. Evaluate site quality and cGMP compliance risk, communicate risk and implement mitigation plans to reduce the risk to Pfizer and to Pfizer's customers. Enable quality strategy and drive changes to support manufacturing product transfers associated with the sites. Interface with relevant functions (Regulatory, GCMC, other PGS site quality, supply chain, procurement, etc.). Endorse site QO budgets, staffing plans, QO organization and hiring/development of colleagues for key site QO positions. Provide support and GMP review for major site capital projects. Visit sites to review organization, product issues, facilities, capital projects, audit status, regulatory inspection status, complaints, operations and related topics. Provide performance management and development for direct reports (Site QO leaders). Collaborates with counterparts in Regulatory, Manufacturing, Legal, Supply Chain and other groups on projects and issues. Collaborates with site QO Center Leadership, Site Leaders and QO OpU Leaders on site quality initiatives and issues. Ensuring that sites monitor, trend and report Quality metrics in a highly disciplined way to drive continuous improvement and ensure a compliant state is maintained Fostering a culture where innovation, science and risk-based quality and colleague engagement thrive. Active member of the Aseptic Quality Forum
The candidate must have a thorough understanding of quality systems and global cGMP compliance requirements as they apply to commercial manufacturing. Expertise and substantial experience in aseptic manufacturing and/or quality oversight is required. Demonstrated experience in quality decision-making in a highly complex environment is essential.
Additionally, the successful candidate must be flexible with regard to changing and conflicting priorities, able to easily shift gears in terms of behavior and attitude in response to ambiguity and the needs of the situation. Candidates will need the ability to address obstacles with energy and determination and exhibit commitment to change and passion for Pfizer's best interests. Candidates should have the leadership skills necessary to engage, influence and motivate colleagues at all levels in the organization at all times, especially during periods of intense change.
Minimum Qualification Requirements:
BSc in Chemistry, Microbiology, Engineering or related scientific field; MSc, MBA or Ph.D. in Pharmaceutical related field preferable.
Proven leadership/facilitation skills and being able to involve several levels of an organization to successfully meet the objectives.
Experience working with complex organizational and ability to w ork across functions and with all levels of the organization where the incumbent may not have direct authority.
Strong organizing and planning skills and a high sense of urgency.
Demonstrated change agility to successfully manage high degree of complexity and priorities.
Experienced with Quality Risk Management tools.
Demonstrated ability to operate with agility in a highly diverse environment.
Proven ability to work long-distance with direct reports and supervisor maintaining effective communication across multiple levels of the organization across diverse cultures.
Demonstrated excellence in developing & managing effective teams.
Minimum 15 years of relevant experience, including 10 years experience in the pharmaceuticals and consumer industries, performing manufacturing, technical services, research or QA functions. Knowledge and experience in aseptic manufacturing operations
Minimum 10 years QA-related experience is necessary and 5 years of site Quality management experience is preferred.
Demonstrated knowledge of US, European and global cGMPs, compliance issues, inspectional trends, industry quality assurance practices and systems, and personal management skills.
Must be fluent in English.
The candidate must have had center or site operational experience in a GMP-regulated environment with a proven track record of effectively supporting a moderate to large size quality unit. The ability to communicate effectively at all levels of the organization is essential. Willingness to be inclusive and embrace team principles is necessary. The candidate must be self-motivated and flexible with the ability to work effectively in a dynamic, problem-solving environment.
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.
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Last Date to Apply for Job: July 5, 2017
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