Job description
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.
Position Summary
The Site Quality Operations Leader (SQOL) is responsible for the operational and strategic management of a diverse range of quality control, quality assurance and quality system operations to support Clinical and Commercial manufacture for small molecule APIs, biologic drug substances and sterile and non-sterile drug products, including medical devices. The SQOL partners with Site Operations, Other Pfizer Sites, Co-Development, Analytical Research and Development and other stakeholders to drive regulatory excellence, ensures a supply of quality products from the site which are compliant with regulatory requirements to meet customer needs and develops talent.
The SQOL is accountable for the product quality, regulatory compliance, quality systems, and processes for the site (including 3rd parties under the responsibility of the site). The scope of this role also includes quality budget and resources planning, quality performance metrics/quality dashboard, quality strategic planning, quality goals and objectives, and quality specific projects. The SQOL is accountable for providing leadership to the site in establishing compliance with marketing authorizations of all materials, packaging components, in-process and final commercial products with established specifications, compliance with regulations and other applicable standards. The incumbent is also responsible for working closely with Pfizer Global Supply (PGS), Worldwide Research and Development (WRD) and Global Regulatory Affairs (GRA) teams to develop strategies on new product introduction for diverse new products.
This position will have a dual reporting relationship to the Kalamazoo Site Leader and the OpU Quality Operations Leader and will be a member of both the Kalamazoo Site Leadership Team (SLT) and the Cluster 3 Quality Leadership Team.
Position Responsibilities
Relationships: Achieves compliance and business results through Partnerships between Quality and Operations and other site/cross site functions e.g PharmSci, Regulatory, Co-Development teams, etc. Is an active member of the Site Leadership Team.
High Performance Culture: Creates a high achieving Quality Operations team with goals and values aligned with other team members and operations, collaborative team environment, and high-performance culture within the site Quality Operations organization.
Operational Excellence: Drives innovation and continuous improvement through Operational Excellence(OE) in all QO activities and supports OE throughout the site.
Talent Management Focus: Oversees the conduct of Talent Management programs to develop future Pfizer leaders and the creation of robust succession plans for the Site Quality Operations Organization. Directs, oversees and participates in the recruitment, selection, promotion, termination and performance management of site personnel in leadership and critical roles. Leads the following activities:
- Job Descriptions for Reports
- Training curricula/records
- Development Plans
- Performance Appraisals
- Coaching of Direct reports
Safety: Ensures that all QO operations are performed in a safe environment in accordance with all applicable EHS policies and procedures.
Issue Resolution: Ensures the creation and implementation of clear and timely action plans for issue resolution with appropriate escalation, communication, and closure.
Regulatory Excellence: Ensures sustainable regulatory excellence through systems, science, people, and continuous process improvements. Ensures a favorable site regulatory profile through constant inspection readiness programs; ensures successful Board of Health inspections. Creates effective relationships with BOH to create trust and credibility. Prepares the site for changes to regulations.
Quality Systems: Ensures compliant site Quality Systems and marketing authorizations.
PQS: Responsible for the implementation of all Pfizer Quality Standards and ensures objectives and action plans that are not already included in the above accountabilities.
PQS: Responsible for the implementation of all Pfizer Quality Standards and ensures objectives and action plans that are not already included in the above accountabilities.
ICH and Industry Standards: Drives understanding of ICH Q8, Q9, Q10 and other appropriate industry standards across the site organization. Follows actively and anticipates impact of emerging regulations on site operations and prepares site for implementation and change, as appropriate
Product Disposition: Ensures independent and timely product disposition using validated processes, analytical methods, and documented decision-making processes.
Quality Technical Support: Fosters science through the establishment and work of the Quality Technical Support function
Technology and Science: Holds self and others accountable for making decisions, solving problems, or driving improvements through a sound understanding of the technology and science of the products.
Quality System: Ensuring the quality system requirements are effectively established and effectively maintained in accordance with regulatory compliance. Ensures the quality policy is disseminated across all levels of the organization.
Reporting on the performance of the quality system to Management with Executive Responsibility, including the adequacy and effectiveness of the quality management system and any need for improvement.
Ensuring that the processes needed for the quality management system (QMS) are documented.
Regulatory Compliance: Ensuring the promotion of awareness of the applicable Regulatory Compliance and QMS requirements throughout the organization.
Education and Experience
- 15 or greater years of manufacturing, quality or engineering experience in the biotech or pharmaceutical industry with a BS/BA Degree in Science/related field
- Greater than 10 years of Quality Operations experience and familiarity with Drug Product manufacturing. API experience preferred.
- Experience leading people leaders and directing a large, complex organization. Previous Site Quality leadership experience preferred
- Experience influencing Board of Health inspections and successful interactions with inspectors preferred
Ideal candidates will have prior experience and demonstrated success in most, if not all, of the following:
- Making sound and effective decisions under pressure
- Managing a Quality/Operations function with product release responsibilities
- Experience in at least two quality and/or science areas
- Working in functions outside Quality/Operations, e.g. Technology, Validation, Operations, Regulatory
- Working with other manufacturing and R&D sites to understand a broader perspective
- Exposure to Regulatory inspections including interactions with Board of Health representatives and responding to Board of Health observations
- Working with multicultural, cross-functional work teams
- Advancing a quality culture in a manufacturing environment
- Evaluating and continuously improving site Quality Systems
- Managing managers and teams
- Project management
- Finance planning and budgeting
- Developing and implementing a quality business strategy
Work Location Assignment: On Premise
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
PHYSICAL/MENTAL REQUIREMENTS
Ability to stand for 1 hour at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Primarily standard work hours with some exceptions to meet business needs. Some travel will be required to support network and sister site initiatives; ~10% required travel.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Other Job Details:
- Last Date to Apply for Job: May 15, 2023
- Eligible for Relocation Package: Yes
- Eligible for Employee Referral Bonus: Yes
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.
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