Associate Director, Quality Assurance, New Acquisitions

Job description

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve 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 world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s 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 we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C, revolutionary improvements in HIV treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers. We set and achieve bold ambitions in our fight against the world’s most devastating diseases, united in our commitment to confronting the largest public health challenges of our day and improving the lives of patients for generations to come. 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. Knowledge, Experience & Behaviors: 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. 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. These considerations mean actual compensation will vary. 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*. For additional benefits information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing * Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States:Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact ApplicantAccommodations@gilead.com for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action,