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Job Title: Site Quality Operations Leader (Diagnostics)
Location: South San Francisco, CA United States
Position Type: Full Time
Post Date: 05/30/2024
Expire Date: 07/30/2024
Job Categories: Biotechnology and Pharmaceutical, Healthcare, Other, Installation, Maintenance, and Repair, Manufacturing and Production, Other / General, Science, Executive Management, Quality Control, Medical
Job Description
Site Quality Operations Leader (Diagnostics)
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.
Serve as the audit process end-to-end subject matter expert and manage critical audit process and strategy projects that contribute to efficient, effective, and compliant quality assurance processes.
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 International regulatory requirements, and policies and procedures within Pfizer that are applicable to the processes and systems within the scope of the business unit.
Experience representing organization or company externally.
General Aspects

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, product release and complaints.
Ensure device design, development, commercialization, complaint, and manufacturing documentation of medical devices and MDCPs meet appropriate regulatory requirements by providing guidance through all stages of life cycle management in accordance with 21 CFR 820, ISO 13485, IEC 62366, IEC 62304, ISO 14971, In Vitro Diagnostic Directive Regulation (IVDR), ISO 61010, Clinical Laboratory Improvement Amendments (CLIA) and applicable internal procedures.
Serve as a subject matter expert (SME) on internal procedures, medical device / MDCP regulations, and the Quality Management System (QMS).
Provide support for quality investigations related to Device Master Records (DMR), CAPAs, laboratory investigations, external suppliers, or complaints.
Responsible for working with external contractors related to MDCPs ensuring consistency and compliance with regulatory expectations and company standards including leading and supporting investigations of significant quality and/or regulatory events associated with external suppliers.
Monitors changes to global regulations and ensures 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.
Provide support for audits and inspections by FDA, notified bodies, competent authorities, and other third parties.
Organizational Relationships

Device development teams – device development leads, human factors subject matter experts, design engineers and device development scientists.
Co-development team – drug product and device/IVD SMEs.
Quality Assurance
GCMC (Regulatory)
Medical Affairs
PGS – manufacturing sites and post launch device team.
External designers and contract manufacturing organizations.
External vendors and suppliers
Qualifications & Requirements
Education, Skills and Experience

Bachelor’s Degree and 10+ years of experience.
Proven technical knowledge and application of root cause analysis (RCA) and CAPA activities.
Demonstrated in-depth knowledge of relevant global regulations and guidelines and evolving legislation.
Excellent organizational, analytical, strategic, interpersonal, written and oral skills.
Thorough understanding and application of cGMP and the principles and concepts of relevant quality processes and systems.
Thorough understanding and application of Country Specific Standards.
ASQ CQE Certification
ISO 13485 Lead Auditor Certification
Technical Skills Requirements

Experience interacting with FDA, EU investigators, notified body and other regulatory agencies in audits or submissions.
Deep understanding of compliance and quality management including procedures and audit readiness requirements.
Broad experience within regulated area (policies, procedures, and processes).
Proficient in Informational Systems and Databases used by Quality Assurance.
Experience and knowledge in interaction with Contract Laboratories and/or manufacturers.
Leadership experience supporting individual development to maximize each colleague’s potential and recognizing individual and team performance through full use of available processes including mission awards, site communications and individual recognition.

Working knowledge of ISO 9001, ISO 13485, ISO 14971, 21 CFR 820, 21 CFR 4, CLIA and the EU Medical Devices and In Vitro Diagnostics Regulation.
Familiarity with EN 62366, EN 61010, and EN 62304.
Able to learn and apply established procedures in a reliable and consistent manner.
Capable of working independently with minimal supervision.
High level of attention to technical details and accuracy.
Able to prioritize multiple responsibilities and to work on multiple tasks simultaneously.
Able to work collaboratively in cross functional teams.
Excellent communication (e.g., oral, written, presentation) and interpersonal relationship skills.
Proficiency in general computer software such as word processing, spreadsheets, presentations.
Understand Good Manufacturing Practices (GMP).
Strong leadership, negotiation, interpersonal, communication, and facilitation skills
Comfortable working and making risk-based decisions, interpreting regulations, and explaining device quality system principles.
Proven problem-solving skills

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.


Sitting, ability to travel, driving license.


10% to 15% potential travel

Work Location Assignment: On Premise

Other Job Details:

Last day to apply: June 5, 2024
Eligible for Relocation Assistance: Yes
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Company Description:
Over nearly two centuries, Pfizer has developed a sophisticated, robust, and agile manufacturing infrastructure by investing in research and development with the sole purpose of getting crucial medicines to patients in need. From the mass production of penicillin to the COVID-19 vaccine, we’ve never lost sight of our compliance, safety, and quality standards. Pfizer remains committed to our ongoing legacy of manufacturing excellence.
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