Compliance Officer at Scania managing the implementation of compliance systems and fostering a culture of integrity. Providing advisory support and promoting compliance within the organization.
About the role
- Director of Quality Compliance and Audits at Gilead managing global GMP and GDP audit programs. Leading audit teams and ensuring compliance in manufacturing and supply networks.
Responsibilities
- Provide strategic leadership and governance for Gilead’s global GMP and GDP audit program.
- Lead and develop a team of auditors; ensure high-quality audit execution across global manufacturing and supply network.
- Manage and develop an auditing team, including work planning and prioritization, performance monitoring, coaching, feedback, and formal performance reviews.
- Establish and execute a risk-based annual audit plan.
- Conduct and support global GMP and GDP audits of Gilead internal manufacturing sites and external partners.
- Promote awareness of current regulatory expectations across clinical and commercial manufacturing platforms.
- Collaborate with cross-functional stakeholders to identify compliance gaps, emerging risks, and opportunities for proactive compliance or continuous improvement initiatives.
Requirements
- BS/BA degree in Biology, Sciences, or related discipline and a minimum of 12 years or related experience; or MS/MA degree in Biology, Sciences, or related discipline and a minimum of 10 years of related experience; or Equivalent combination of education and experience.
- Demonstrated experience in the biotechnology or pharmaceutical industry is required.
- Proven GMP/GDP auditor with experience conducting audits and leading, managing, and developing a team of auditors.
- Experience engaging with Health Authorities during regulatory inspections is desirable.
- Prior experience within a regulatory authority is desirable.
- Expert knowledge of GMP and GDP regulations, global regulatory expectations, and inspection practices.
- Excellent verbal, written, and interpersonal communication skills, with the ability to communicate effectively across technical, operational, and executive audiences.
Benefits
- Company-sponsored medical, dental, vision, and life insurance plans
- Discretionary annual bonus
- Discretionary stock-based long-term incentives
- Paid time off
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