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Associate Director, Quality Assurance Compliance

Foster City, CA, USA | Major Biopharmaceuticals Company

  • Industry:
    Pharmaceutical / Biotech
  • Position Type:
  • Functions:
    Quality Assurance
  • Experience:
    10-12 years
Job Description:
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Job Description

Working in QA at Gilead:


Quality Assurance delivers on Gilead’s commitment to bring life-changing therapies to patients through the robust QA processes and systems. Our approach is agile, innovative and collaborative and our teams are genuinely committed to the rapid delivery of safe life changing therapies. 


As part of the broader Pharmaceutical Development & Manufacturing (PDM) team you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. 


You will see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through on-going development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining QA within PDM, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.


Meet the worldwide QA Team: https://qualityassurance-careers.gilead.com/


Specific Responsibilities: 


The Associate Director- QA Compliance, – will report to the Director of Supplier Management and Global Auditing. This is a position that will conduct audits as needed and will assist in leading a group of auditors that performs GMP and GXP audits for global suppliers. The Associate Director –QA Compliance will maintain consistent audit standards, reports, practices, and maintain performance in alignment with expectations and key metrics. This position will work closely with each of the GMP/GDP audit teams and global support functions at Alberta, Cork, Foster City, Oceanside, and San Dimas.  


Manage some of the day-to-day activities of supplier auditors, including audit assignments and prioritization, monitoring task performance, reviewing audit reports, and generating metrics to measure auditor performance

Conduct global vendor audits as needed for various types of Gilead GxP suppliers which may include contract manufacturing and packaging facilities as well as providers of APIs, raw materials, product contact consumables, contract testing laboratories, and warehouses / distributors in support of Gilead’s clinical and commercial oral and parenteral dosage formulations and associated medical devices.

Manage all aspects of the audit lifecycle for assigned audits: scheduling, planning, issuing agendas, executing, issuing reports, evaluating responses, requesting clarification, issuing CA/PA, and closing.

Ensure that the audit agenda is risk-based and has the appropriate internal and/or external subject matter experts as part of the audit team.

Work directly and collaborativelywith Gilead cross-functional departments to gather key information and feedback for conducting vendor audits 

Ensure completion of correct CA/PA when required to address compliance concerns identified during audits.

Participate in the development, implementation and maintenance of procedures and templates to ensure continuous improvement of the auditing process. 

Identify compliance risks and escalate issues to appropriate levels of management for resolution.  

Promote awareness across the commercial and clinical manufacturing platform of current regulatory agency requirements and trends

Develop and report trends based on internal and external regulatory observations to better focus the scope of audits

Ensure consistency with audit report observation classification, rating, and content  

Participate or lead continuous improvement initiatives 

Other responsibilities as required.


Travel is required up to 30%


Essential Functions:


Supports Compliance management in maintaining the company’s Compliance program.

May manage the day-to-day activities of one or more individual contributors, including task assignment and prioritization, monitoring task performance, and conducting performance reviews.

Ensures awareness of compliance requirements and responsibilities within the function.

Establishes excellent working relationships with compliance/quality groups.

Responsible for maintaining current knowledge of applicable compliance requirements through attendance at industry and regulatory agency sponsored meetings and seminars.

Responsible for providing guidance on interpretation and application of existing and new requirements.Provide guidance to assigned departments and management when specific compliance issues arise. 

Assists in evaluation and implementation of standard operating procedures and systems needed to comply with requirements. 

Leads various types of audits or projects or supervises contractors or auditors. Audits may include internal systems audits, external vendor audits, or document reviews.

Assists in regulatory agency inspections. Assists in coordination of responses to any regulatory agency findings.

Knowledge, Experience & Skills:


Essential:


Demonstrates excellent verbal, written, and interpersonal skills.

Demonstrates a thorough knowledge of compliance requirements, and an understanding of current global and regional trends in compliance.

Is capable of taking a leadership role in updating and preparing the company for changes in regulations.

Is capable of leading a small team in development of systems and procedures and implementation.

Is well recognized as a knowledgeable resource for QA compliance advice in other departments.

10+ years of relevant experience in the pharmaceutical industry and a BS or BA.

8+ years of relevant experience and a MS.

Desirable:


Knowledge of domestic and international regulations including 21 CFR Parts 11, 203, 205. 210, 211, 600, 610, 820; EudraLex Volume 4 and applicable annexes; and Health Canada R.S.C., 1985, F-27, Section 30; as well as ICH, ISO and USP / EP compendial standards and principals.

Skilled auditor with five years’ experience and ability to perform investigative audits.

Experience managing quality functions and experienced pharmaceutical professionals

Detailed knowledge of the manufacturing and testing processes associated with APIs, Oral Solid Drug Product, Liquid Formulations, Biologics, Aseptic Fill / Finish, Primary and Secondary Packaging, and Clinical Kitting, and Warehousing / Distribution.

Practical understanding of current GMP and GDP concepts and industry practices. 

Educational degrees related to Life Science


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