Product Quality Lead

At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID-19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact.

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Job Description

The primary responsibility for this position is to establish phase appropriate product specifications for Gileads clinical and commercial addition this position is responsible for end to end product quality strategy and serves as the QA main point of contact on the PDM Product Strategy Team(s).

The position holds a scientific and technical understanding of drug development and commercialization and able to provide effective quality oversight and feedback for their assigned program(s) by liaising between the Product Strategy Team Manufacturing and Analytical functions Supply Chain RA CMC and the wider PDM Quality organization.

Job Functions:

• Expert in analytical control systems assuring network-wide harmonization of control systems by proactive lifecycle management technical leadership and ownership.

• Provide technical oversight of product specification setting and justification based on scientific approach. Deep understanding of analytical methods (development validation transfer and monitoring) and product (process development CQA analysis stability comparability etc).

• Ability toevaluate Global product filing strategies with core PDM Team for implementation.

• Provide timely support for health authority interactions on the product authorship/review (as needed) relevant health authority information requests for in-process controls process development (comparability) method validation specifications reference standard and stability sections of regulatory submissions.

• Build internal knowledge and capabilities on product control strategies. Proactively share expertise with other functional groups to generate alignment and improvement opportunities.

• Accountable for end-to-end quality compliance of the assigned product/program which include but not limited to providing strategic leadership and direction for quality and compliance activities and owns the overall product risk log.

• Serve as the primary Quality representative in the PDM meeting.

• Lead Product Quality Teams (PQT) supporting the product/program and ensure visibility and communication of strategy key project timelines and CMC milestones.

• Monitor and review cross-functional process and product data to identify trends to ensure significant quality and compliance risks are identified mitigated and if necessary escalated in a timely manner.

• Review and approve the strategy for change control(s) impacting the product/program lifecycle.

• Provide technical oversight of Major and/or Critical Deviations CAPAs Biological Product Deviation and Complaints.

• Contribute to Review Regulatory Submissions (IND IMPD BLA NDA MAA) and assist with regulatory communications as needed (e.g. responses to agency information requests the Notified Body Option).

• Provide oversight for changes to drug substance and drug product CMC details.

• Accountable for PAI/PLI readiness and supports Gilead PAI/PLI inspection preparation efforts and post-PAI/PLI follow up as a Subject Matter Expert with Quality representatives at CXO(s) and Gilead Sites.

• Support drug substance and drug product technology transfer and new product launches.

• Participate in drafting commercial Annual Product Quality Review (APQR) and review/approve Gilead and CMO APQRs for commercial products.

• Accountable for medical device/ combination product quality compliance: engage/liaise with medical device product engineering development and quality teams.

• Facilitate Analytical Strategy (stability strategy specifications Critical Quality Attributes).

• Perform work that requires independent decision making and the exercise of independent judgment.

• Serve as the delegate for direct manager as needed for meeting and decision making.

Knowledge Experience and Skills:

• Well verse in technical requirements for product control systems.

• Strong knowledge and practical experience in analytical chemistry including separation science wet chemistry physicochemical characterization or related areas.

• Strong experience in the assessment of technical data and scientific information is required in order to provide technical reviews for documents and regulatory submissions.

• 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.

• In-depth knowledge in Global requirements/standards for product registration and life-cycle management of product quality.

• Extensive knowledge and experience in technology validation/transfer of Drug Substance and Drug Product.

• Skilled at managing multiple projects and timelines and to facilitate meetings.

• In-depth understanding and execution of Quality Risk Management.

• Ability to track and follow up on actions.

• Excellent in verbal written and interpersonal communication skills.

• Ability to work in a team-oriented approach to address complex issues in a scientifically sound and compliant way.

• Ability to lead and influence a matrix-based cross-functional team.

• Critical and strategic thinking skills and ability to provide pragmatic risk-based and phase appropriate guidance and decision-making even when quality and compliance requirements are not well-defined.

• Extensive knowledge and experience in technology validation/transfer of Drug Substance and Drug Product

Basic Qualifications:

• 12 years of relevant experience and a Bachelors degree in science or related fields;

OR

• 10 years of relevant experience and a science degree MS

OR

• 8 years PhD

Preferred Qualifications:

• Prior Quality leadership and technical management experience in development and/or commercial programs.

• 15 years of relevant experience and a Bachelors degree in science or related fields; or 10 years of relevant experience and an advanced science degree such as MS PharmD PhD or an advanced business degree such as an MBA.

• Demonstrated experience and knowledge in quality assurance in a highly regulated manufacturing environment.

• Direct experience with regulatory health authority submissions (e.g. IND NDA BLA MAA) and/or inspections.

• Broad experience across several including process validation drug development experience packaging/labeling and understanding of Parenteral Oral Solid Dosage and Biologics.

For additional benefits information visit:

Eligible employees may participate in benefit plans subject to the terms and conditions of the applicable plans.

For jobs in the United States:

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