- Identify quality, process, and GMP problems and assure resolution.
- Manage overall process in evaluating site compliance to Pfizer Quality Standards (PQS) and implement appropriate actions.
- Insure implementation of data integrity program within Quality Operations and on-site operations level.
- Manage the overall assurance and disposition of products produced at the manufacturing site.
- Approve (for cases indicated in PQS) quality operations and production quality assurance reports and investigations for deviations from approved manufacturing processes or specifications.
- Review key quality and regulatory documentation and implement appropriate actions.
- Lead and engage the site quality review team (SQRT) and AQRT process to ensure site regulatory compliance to ensure marketed product quality and manage site regulatory inspections.
- Coordinate development of area training plans in order to manage the training, qualifications and educational needs of the Quality Operations colleagues. Manage talent development to assure adequate current capabilities and future succession for critical positions.
- Develop and maintain an organizational structure consistent with the needs and goals, including the preparation and administration of annual performance assessments and discussions.
- Optimize site effectiveness and efficiency to ensure site performance goals are achieved or exceeded without compromising quality and compliance.
- Provide strategic leadership to QO and to the site on quality.
- Be a voice for change and continuous improvement.
- Perform other related duties as assigned or required.
- Responsibility for implementation of Data integrity program in the relevant work area and Insure following up ALCOA principles all over operations.
- Active implementation of Notification to Management procedures.
- Responsibility for compliance with Pfizer Quality Standards.
Experience and Knowledge
Minimum of 10 years related pharmaceutical experience. At least 5 years of demonstrated success leading and developing professional colleagues and developing a staffing/organizational structure in a QO or manufacturing environment. Demonstration of all of the Pfizer manager competencies, including:
- Acts decisively – Makes good decisions in a timely manner based on analysis, experience, and judgment, even with incomplete information or under time pressure.
- Seizes accountability – Takes personal responsibility for own work, pushes self and others to exceed goals and deliver results.
- Leads change – Demonstrates perspective and poise amidst ambiguity and change, and guides others with direction, focus and energy.
- Demonstrates business acumen – Knows how a global corporation works; knowledgeable in policies practices, trends and functions affecting Pfizer, the competitive dynamics of our industry, and how the marketplace is transforming.
Essential Personal Qualifications
- Excellent verbal, written and interpersonal communication skills.
- Exceptional understanding of GMPs and demonstrated leadership management, coaching, development and technical capabilities.
- Strong verbal, written, presentation and interpersonal communication skills. Proven ability to plan, implement, and achieve significant, complex goals and objectives. Demonstrated commitment to achieving objectives in a manner that is supportive of Pfizer values and PGS mission elements.
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