Site Quality Operations Leader

3 weeks ago

San Francisco, United States Pfizer Full time

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

Director SQOL (Diagnostics) is a site role having responsibility for Pfizer’s Diagnostic providing end-to-end quality assurance accountability. This role is the Quality Lead for the site operating in a Legal Manufacturer framework leveraging the expertise from site and across the Pfizer organization.

This position is a member of the Medical Device and Combination Products (MDCP) Quality Operations team within the Pfizer Global Supply (PGS) organization. The incumbent provides quality assurance leadership/guidance of MDCPs related to design controls (21 CFR 820), Quality Management Systems (ISO 13485), risk management (ISO 14971), In Vitro Diagnostic Directive Regulation (IVDR), Clinical Laboratory Improvement Amendments (CLIA), clinical trials, vendors, complaints, post-market surveillance, regulated body inspections, applicable internal procedures, and other applicable regulatory requirements throughout the product lifecycle.

Position Responsibilities
- Set objectives for and manage multiple projects, commercial manufacturing, product release and ongoing work activities of high complexity within a Global Business Unit.
- Manage and lead people, technological and financial resources within the Global Business Unit.
- Direct a team of colleagues who are responsible for process documentation, training and monitoring of key processes and controls within Business Unit Quality Assurance group.
- Develop and implement the strategy for a comprehensive quality control/monitoring program that facilitates consistency and compliance with SOPs, work instructions, Corporate and Healthcare Compliance policies and Regulatory requirements and enables monitoring of processes and standards.
- Lead the identification and initiation of continuous process improvements to enhance the quality of operations, systems and services evaluating compliance with applicable GMP/GDP requirements.
- Support the investigation of and implementation of corrective/preventive actions for quality issues arising within the markets.
- Own the strategy to provide, implement and manage an easily accessible, centrally controlled document management system to store local SOP’s, guidelines and other standard documents and templates.
- Lead/Participate on cross functional projects teams and share knowledge and best practices with Medical and Pfizer counterparts.
- Set expectation for goal setting, ongoing assessment, coaching, performance development and evaluation to motivate direct and indirect reports to develop and maintain a team of highly qualified and diverse personnel that deliver results for department or business line.
- Oversee the training needs of colleagues and alliance partners with regards to procedures, policies and systems and the development of training plans to meet the needs of the business.
- Develop innovative or original ideas and lead business unit projects of a complex nature.
- Develop mid-term plans that impact the achievement of business unit results.
- Act as an enterprise leader in Quality, influencing and partnering with business unit and business leadership, to develop, evolve and strengthen a holistic Quality Management System.
- Innovate to create new strategies and solutions, that are enterprise focused, and seek opportunities and creative ideas to improve the business unit's value and contribution to the enterprise.
- Partner with cross functional leadership in the development of strategies, specifically by proactively identifying risks, providing guidance on risks and partnering with leadership to oversee mitigations across global functions.
- Proactively identify and including quality risks and mitigation scenarios in an integration quality strategy, in partnership with Functional line Pfizer leaders.
- Lead the preparation, conduct and management of mock inspections, as appropriate.
- Develop and maintain policies, standard operating procedures (SOPs), tools, and guidelines (as appropriate) for preparation and conduct of inspections within Pfizer.
- Drive innovative approaches for risk and mitigation calibration across existing and emerging risk areas to establish consistent risk-based approaches. Includes development of uniform risk assessment (including thresholds) and mitigation measures framework.
- Promote broad understanding of the Pfizer Quality Management system and Quality Governance process across the organization and partner lines.
- Lead initiatives to promote a strong Quality Culture across the organization.
- Maintain appropriate level of expertise in US and Inte

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