Associate Director, Quality Assurance, New Acquisitions

About the role

As an Associate Director Quality Assurance at Gilead, you will be a member of the API/OSD/Packaging group. This role is responsible for supporting initial integration of new asset acquisitions into Gilead systems. The role acts as a leader providing hands-on support as well as giving guidance to other QA staff to ensure new product assets are available quickly and compliantly.

Key Responsibilities

• Acts as the overall responsible QA person for transition of small and large molecule Due Diligence assets to active Gilead programs.
• May be the QA lead on Due Diligence projects and ensures high performance and consistency among other Due Diligence QA leads.
• This role may have direct reports but will also provide leadership for staff from other QA teams supporting newly acquired assets.
• Works closely with Product Strategy Team leads to ensure adequate QA coverage on new assets and to ensure onboarding and integration strategy is defendable.
• Supports QA staff on Due Diligence teams and new asset Product Strategy teams to assess and highlight risks and ensure proper communication of risks and proposed mitigations.
• Responsible for providing guidance on interpretation and application of existing and new US requirements pertaining to clinical and commercial phase programs.
• Manage or provide support for QMS records such as deviations (internal & external), CAPAs & Change Controls related to onboarding and integration activities.
• Participate in developing/approving Standard Operating Procedures (SOPs) and other types of documentation to ensure quality objectives are met.
• Participate in the development & delivery of training programs relevant to Due Diligence and onboarding.
• Conduct/participate in gap analyses and risk assessments of processes & procedures against relevant guidelines as well as corporate standards.
• Participate in, or where relevant lead, local and corporate projects, and process improvement initiatives, as required.

Qualifications

• 10+ years of relevant experience in the pharmaceutical industry and a BS or BA
• OR 8+ years of relevant experience in the pharmaceutical industry and a MS
• OR 5+ years of relevant experience in the pharmaceutical industry and a PhD
• Deep knowledge and experience in quality assurance in a highly regulated manufacturing environment.
• Experience in asset acquisition due diligence, product and site assessments, and risk management.
• Demonstrates a highly developed knowledge of clinical phase quality and compliance requirements, and an understanding of current industry trends.
• Capable of assessing and communicating the impact of risks to the business.
• Ability to engage and manage multiple stakeholders to achieve objectives.
• Demonstrates excellent influencing and negotiation skills.
• Excellent verbal, written and interpersonal skills are required.
• Practiced in systematic approaches to prioritization, problem solving, and critical thinking.

People Leader Accountabilities

• Create Inclusion - knowing the business value of diverse teams, modeling inclusion, and embedding the value of diversity in the way they manage their teams.
• Develop Talent - understand the skills, experience, aspirations and potential of their employees and coach them on current performance and future potential. They ensure employees are receiving the feedback and insight needed to grow, develop and realize their purpose.
• Empower Teams - connect the team to the organization by aligning goals, purpose, and organizational objectives, and holding them to account. They provide the support needed to remove barriers and connect their team to the broader ecosystem.

Compensation

The salary range for this position is: $182,070.00 - $235,620.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans.