Senior Director, Global Supplier Quality
United States - California - Foster CityQualityRegularDescripción del trabajo
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
Senior Director, Global Supplier Quality
Gilead Sciences, Inc. is a research-based biopharmaceutical company founded in 1987. Together we deliver life-saving therapies to patients in need. With the commitment and drive you bring to the workplace every day, you will be part of a team that is changing the world and helping millions of people live healthier, more fulfilling lives. Our worldwide staff is a close community where you can see the tangible results of your contributions, where every individual matters, and everyone has a chance to enhance their skills through ongoing development. Our scientific focus has resulted in marketed products that are benefiting hundreds of thousands of people, a pipeline of strong late-stage drug candidates, and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them. By joining Gilead, you will further our mission to address unmet medical needs and improve life by advancing the care of patients with life-threatening diseases.
Working in PDM Global Quality at Gilead:
Pharmaceutical Development & Manufacturing (PDM) Global Quality delivers on Gilead’s commitment to bring life-changing therapies to patients through robust Quality processes and systems. Our approach is agile, innovative and collaborative and our teams are committed to the successful delivery of safe life-changing therapies.
Job Summary:
Gilead Sciences PDM External Quality is currently seeking a leader at the Senior Director level to lead a team of 10 – 15 Quality Professionals to define, lead and manage the Global Supplier Quality program by providing quality oversight of GMP material and commodity suppliers.
Being a member of the External Quality Leadership team, the successful candidate is expected to work collaboratively with internal and external networks to continually improve Gilead’s Global Supplier Quality program, from selection, onboarding, qualification, and routine quality and performance oversight of global and local GMP material and commodity suppliers.
The successful candidate must have demonstrated leadership skills and extensive working knowledge of managing GMP material and commodity suppliers’ performance and relationships.
The successful candidate must have exceptional skills in managing a matrix organization, consisting of Suppler Quality members from each of the internal Gilead’s sites.
In addition, the successful candidate must have a technical understanding of different material categories supporting GMP manufacturing of different Gilead product modalities.
It is important that the successful candidate can influence Gilead’s external network on selection of GMP material and commodity suppliers in alignment with Gilead’s standards.
The successful candidate must be extremely familiar with applicable regulations and requirements with GMP material and commodity supplier management program and clarity of the role and responsibilities between marketing authorization holder and contract manufacturing organizations.
The successful candidate must possess strong communication, influencing and negotiation skills, be able to evaluate options and trade-offs and utilize available resources to achieve the most positive impact to the business and be able to partner with leaders in different PDM functions including Technical Development, Packaging Development and Engineering, Global Manufacturing, Procurement, Regulatory CMC, and the Gilead Site Quality to achieve business objectives.
The successful candidate must have proven track records in leading Global Supplier Quality program in other global biotech or pharmaceutical companies, preferably with established relationship with reputable GMP material and commodity suppliers.
Job Functions:
Execute an integrated and sustainable Global Supplier Quality strategy for Gilead’s clinical and commercial products based on the value proposition for Gilead (Integrity, Inclusion, Teamwork, Accountability, Excellence) and available SMEs.
Develop processes to communicate learnings and drive any related Supplier Quality improvement initiatives to support the development of Gilead’s clinical and commercial products.
Develop a process for exchange of lessons learned across multiple company representatives and identify opportunities for Gilead’s process improvements.
Collaborate with Technical and Quality leadership to identify solutions and processes and align with key partners on implementation of new requirements.
Implement continuous improvement initiatives to drive Global Supplier Quality program and ensure maximum productivity. Ensuring systems are world-class and meet the needs of all internal and external constituencies with an emphasis on process, quality, productivity, budget control, and profitability.
Develop, implement, and monitor Global Supplier Quality program, policies, and procedures to ensure compliance with GxP standards, corporate policies, FDA, EMA, and other regulatory body regulations and guidelines.
Set and drive compliance to department, site and global KPIs.
Evaluate all current Global Supplier Quality systems and processes and recommend and implement appropriate enhancements and training to ensure the achievement of Gilead long-term objectives.
Professional organization engagement and representation; benchmarking in industry networks.
Provide guidance to the business teams on technical regulatory requirements and lead and assist where needed.
Participate in different internal business and technical forums as Quality’s voice for GMP material and commodity suppliers’ oversight.
Conduct regular review and assessment of regulatory intelligence and communicate any concerns, trends, gaps, alerts to Quality management in a timely fashion.
Think and act globally to anticipate potential problems and risks related to regulatory compliance expectations.
Approximately 20% travel is expected.
Knowledge, Experience and Skills:
• Expert in quality requirements pertaining to GMP material and commodity supplier management with strong emphasis on quality and performance management inclusive of risk identification and mitigation.
• In-depth understanding and application of GMP principles, concepts, best practices, and standards in the US and internationally.
• Demonstrated ability to develop and improve complex concepts, techniques, and standards and new applications based on quality principles and theories.
• In-depth knowledge of Global requirements/standards for GMP material and commodity suppliers’ life-cycle management.
• Demonstrated ability to develop solutions to complex problems, which require a high degree of ingenuity, creativity, and innovativeness, and where precedent may not exist.
• Excellent verbal, written, and interpersonal communication skills.
• Ability to interact with regulatory agencies is needed and possesses the ability to represent Gilead in public forums.
• Demonstrated experience and ability to manage team of highly technical staff.
• Expert in managing resources to address competing projects and timelines.
Basic Qualifications:
12 - 15 years of relevant experience and a bachelor’s degree in science or related fields; or 8+ 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 leadership experience in a complex organization a must.
Expert knowledge in technical and regulatory requirements pertaining to GMP material and commodity supplier management is a must.
Biopharmaceutical or Pharmaceutical experience a must.
Prior experience leading Global or Local Supplier Quality organization in a global biotech or pharmaceutical company is a must.
Experience with GMP material and commodity category management covering the different Gilead product modalities is preferred.
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.
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