Director, External Quality Strategy and Operations

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
 

Gilead Sciences PDM External Quality is currently seeking a leader at the Associate Director/Director level to lead a team of Quality Professionals to drive strategy development and implementation of standardized communication, training and rollout of Gilead’s Quality standards, requirements, systems and tools to the Gilead’s contract organization global network.

• The successful candidate must possess expertise in leading cross-functional business and quality process mapping, identifying improvements to existing business and quality processes and leading Operational Excellence (OpEx) initiatives that span multiple PDM External Quality teams.

• Being able to utilize the tools & training associated with business process management in a strategic capacity.

• Responsible for the management of quality agreement, coordination of quarterly management review metrics collection, annual product quality review.

• Define and align the requirements and processes for contract organizations’ quality event management inclusive of deviation and investigation, corrective and preventative action, and change control. 

• Successfully and consistently roll out Gilead’s Partner Collaboration Quality System module to Gilead’s contract organization global network. 

• Key representative for Gilead’s Quality Transformation initiatives.

• The leader must be able to evaluate options and trade-offs and utilize available resources to achieve the most positive impact on the business and be able to partner with leaders in PDM External Quality and Global Quality to achieve business objectives. 

• The successful candidate must have proven track records in leading Operational Excellence in Quality organization in a biotech or pharmaceutical development environment and strong knowledge of cGMP quality systems.

Job Functions:

• Lead cross-functional business and quality process mapping and OpEx initiatives. This requires exceptional facilitation skills to gather SME input to design clear end-to-end business and quality processes that are practical and meaningfully improve current processes / approaches, in addition to expertise in business and quality process and OpEx methodologies and tools

• Ability to analyze situations and/or data, applying sound judgment and reasoning, to identify and resolve problems and make recommendations. These will typically be high impact processes that have implications across multiple PDM Global Quality teams.

• Interface with members of the PDM Global Quality Leadership Team to drive meaningful process improvements in PDM Global Quality.

• Utilize excellent analytical, communication and influencing skills, as well as a keen problem-solving ability, to drive helpful changes and continuous improvements.

Basic Qualifications:

• A BS in life sciences or a relevant business area with 12+ years of varied post-graduation experience in Pharmaceuticals, Biosciences or a related industry required OR

• MS with 10+ years of relevant experience OR

• PhD with 8+ years of relevant experience

• Experience leading cross-functional biopharma strategic initiatives.

• Experience leading business process mapping with a variety of stakeholders and SMEs.

• Experience with business process mapping tools such as Visio.

• Strong interpersonal skills and conflict resolution skills.

• Solid understanding of current industry, quality and compliance trends.

• Demonstrated ability to understand complex and complicated situations and to strip out complications.

• Outstanding verbal and written communication skills with the ability to effectively interact with all levels within the organization.

The salary range for this position is:

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.

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 [email protected] for assistance.

For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster.

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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, including an investigation conducted by the employer, (c) consistent with the  legal duty to furnish information; or (d) otherwise protected by law.
 

Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

Please apply via the Internal Career Opportunities portal in Workday.