Site Quality Operations Leader (Diagnostics)

Pfizer Inc.

South San Francisco, CA

Job posting number: #7250299 (Ref:pf-4912598)

Posted: May 31, 2024

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 

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
  • Safety
  • PGS – manufacturing sites and post launch device team.
  • External designers and contract manufacturing organizations.
  • External vendors and suppliers

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. 

General 

  • 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.

PHYSICAL/MENTAL REQUIREMENTS

Sitting, ability to travel, driving license.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

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

The annual base salary for this position ranges from $161,600.00 to $269,400.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

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.  This position requires permanent work authorization in the United States.

Quality Assurance and Control

#LI-PFE


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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More Info

Job posting number:#7250299 (Ref:pf-4912598)
Application Deadline:Open Until Filled
Employer Location:Pfizer Inc.
New York,New York
United States
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