Quality Assurance delivers on Gileads 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 committed to the successful delivery of safe life-changing therapies.
Job Summary:
Gilead Sciences is currently seeking a Senior Director level position to be the leader of Analytical Quality Assurance (AQA) Team in the Pharmaceutical Development and Manufacturing (PDM) organization. The AQA Team provides quality oversight for GMP activities within Analytical Development Operations and Quality Control at Gilead Foster City site, Contract Testing Laboratories, and testing operations at Contract Manufacturing Organizations. The leader of AQA Team is a key strategic member of Quality Assurance management team in continually assessing quality systems, providing guidance and direction for implementation of effective and efficient quality processes. The candidate must have demonstrated leadership skills and with in-depth understanding of analytical method development, qualification, validation, method transfer and method lifecycle management covering direct materials, excipients, active pharmaceutical ingredients, oral solid dosage, small molecule parenteral, and biologics. In addition, the candidate must have practical experience in applying phase appropriate analytical method qualification and validation requirements to support regulatory submissions, be able to evaluate options and trade-offs and utilize available resources to achieve the most positive impact to the business and be able to partner with leaders in different technical teams and the wider PDM Quality organization to achieve business objectives. The successful candidate must have proven track records in leading technical teams in a biotech or pharmaceutical development environment and strong knowledge of cGMP quality systems and have extensive experience in managing contract testing laboratories.
Job Functions:
Execute an integrated and sustainable external quality strategy and company content priorities for Gileads clinical and commercial products and contract organizations based on the value proposition for Gilead (Integrity, Inclusion, Teamwork, Accountability, Excellence) and available SMEs.
Develop processes to communicate learnings and drive any related activities for Gileads clinical and commercial products in support of a robust compliant lifecycle for the programs.
Develop a process for exchange of lessons learned across multiple company representatives and identify opportunities for Gileads process improvements.
Collaborate with Technical and Quality leadership to identify solutions and processes and align with key partners on implementation of new requirements.
Implement continuous improvement initiatives to drive quality programs and ensure maximum productivity. Ensure systems are world-class and meet the needs of all internal and external constituencies with an emphasis on process, quality, productivity, budget control, and profitability.
Develop, implement, and monitor quality programs, policies, and procedures to ensure compliance with GxP standards, corporate policies, FDA, EMA, and other regulatory body regulations and guidelines.
Set and drive compliance to department, site and global KPIs.
Evaluate all current quality systems and processes and recommend and implement appropriate enhancements and trainings to ensure the achievement of Gilead long-term objectives.
Professional organization engagement and representation; benchmarking in industry networks.
Provide guidance to the business teams on technical regulatory requirements and lead and assist where needed.
Participate on Joint Steering Committees (JSC) and Joint Management Committees (JMC) as Qualitys voice for contract organizations oversight.
Conduct regular review and assessment of regulatory intelligence and communicate any concerns, trends, gaps, alerts to Quality management in a timely fashion.
Think and act globally to anticipate potential problems and risks related to regulatory compliance expectations.
10 15% travel based on strategic plan.
Knowledge, Experience and Skills:
Expert in quality requirements pertaining to analytical method development and lifecycle management for direct materials, excipients, active pharmaceutical ingredients, oral solid dosage, small molecule parenteral, and biologics.
In-depth understanding and application of GMP principles, concepts, best practices, and standards in the US and internationally.
Demonstrated ability to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.
In-depth knowledge in Global requirements/standards for product registration and life-cycle management of product quality.
Demonstrated ability to develop solutions to complex problems, which require a high degree of ingenuity, creativity, and innovativeness, and where precedent may not exist.
Excellent verbal, written, and interpersonal communication skills.
Ability to interact with regulatory agencies as needed and possesses the ability to represent Gilead in public forums.
Demonstrated experience and ability to manage team of highly technical staffs.
Expert in managing resources to address competing projects and timelines.
Basic Qualifications:
A BS in science or a related field with at least 12 years of relevant experience, or an advanced science degree (e.g., MS, MD, PharmD, PhD) or an advanced business degree (e.g., MBA) with at least 8 years of relevant experience.
Prior leadership experience in a complex organization a must.
Expert knowledge in technical and regulatory requirements pertaining to analytical method development and lifecycle management a must.
Biopharmaceutical or Pharmaceutical experience a must.
Prior experience in contract testing laboratory management a must.
Experience with different pharmaceutical modalities, e.g., active pharmaceutical ingredients, parenteral, biologics, and medical device preferred.
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Job Requisition ID R0043908
Full Time/Part Time Full-Time
Job Level Director
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