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Please log onto your Internal Career Site to apply for this job.Job Description
Executive Director, Quality Assurance Biologics - Foster City, CA
- Responsible for an effective quality management system in place to achieve the quality objectives of global biologics operations.
- Responsible for strategy creation, direction, and execution of global quality biologics.
- Directs appropriate resources to effectively maintain the quality management system and leads continuous improvement efforts.
- Responsible for progressing the suitability and effectiveness of the global biologics quality management system and GMP compliance through participation in organizational quality management reviews.
- Leads biologics operations leadership team (Oceanside, CA, Foster City, CA, Morris Plains, NJ) in developing business/operational plans across multiple functions and accountable for implementation.
- Member of senior management team focusing on strategic issues across multiple functions and sites.
- Lead in the preparation and quality/compliance review of BLA/IND/IMPD regulatory submissions for US and worldwide health agencies.
- Collaborate with Process Development and Technical Manufacturing Ops teams for new biologic product introductions and provide quality leadership throughout all phases of product development.
- Primary lead with regulatory agencies as required, representing Gilead during health authority inspections
- Provides leadership direction for a multi-functional group of quality professionals, aligned with company culture that recognizes market practices and regulatory trends to achieve a uniform Quality strategy.
- Coaches, leads and mentors direct reports and builds a highly capable team through the attraction, training and development of the necessary skilled professionals to meet business needs.
- Member of leadership team networking with Gilead’s senior management on matters concerning several functional areas and/or customers impacting biologic operations.
Knowledge & Skills
- Knowledgeable of the principles of GxPs, specifically to biologics.
- Demonstrates ability to quickly establish credibility with diverse audiences and be perceived as a leader.
- Demonstrates excellent verbal, written, and interpersonal communication skills, as well as excellent influencing skills.
- Demonstrates significant in-depth understanding of business objectives and how they translate into quality priorities.
- Has the experience and confidence necessary to work with senior executives, and the ability to build rapport with employees at all levels.
- Demonstrates experience and ability to manage staff.
- Able to develop solutions to complex problems, which require a high degree of ingenuity, creativity and innovativeness, and where precedent may not exist.
Education & Experience
- 15+ years of relevant experience in biopharmaceuticals, biotech or pharmaceuticals industry, and a Bachelor’s degree in science or related fields.
- 10+ years of relevant experience and an advanced science degree such as MS, MD, PharmD, PhD or an advanced business degree such as an MBA.
- Prior people management experience, which may include managing people managers.
- Extensive knowledge and experience in quality assurance in highly regulated manufacturing environments.
- Broad experience across areas such as CMO QA, Validation, Drug development experience and/or Pharmacovigilance and proficiency of Parenteral, Aseptic and API operations is beneficial.
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Please log onto your Internal Career Site to apply for this job.