Sr Manager, Quality Assurance - Global Supplier Quality (Parenteral Pack and Devices)
Sr Manager, Quality Assurance - Global Supplier Quality (Parenteral Pack and Devices)
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$ 143225 - 185350
1 Vacancy
Job Description
At Gilead were creating a healthier world for all people. For more than 35 years weve 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 worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.
Every member of Gileads 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 were 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
Gileads mission is to discover develop and deliver therapies that will improve the lives of patients with life-threatening illnesses worldwide. We are seeking a highly motivated Senior Manager to join the Global Supplier Quality team within External Quality Operations. This position will support Parenteral Packaging (e.g. vials syringes stoppers) and Device categories. The role is designed to provide hands-on operational execution and external relationship management support for the material categories. The individuals will manage global changes investigations and onboarding activities while also growing into broader leadership roles over time. The role is highly visible offers tremendous growth potential and requires technical acumen strong leadership and collaboration with cross-functional stakeholders across Quality Global Supply Chain Manufacturing Operations and Technical Development.
Key Responsibilities
Provide strategic and operational quality oversight for suppliers of materials in assigned categories across internal manufacturing sites and external partners
Support and lead supplier investigations deviations and CAPAs to ensure timely and effective resolution
Manage supplier-initiated changes and global change notifications including impact assessments and cross-functional implementation
Partner with cross-functional teams (Quality Supply Chain Technical Development etc.) in supplier selection onboarding and lifecycle management
Lead and coordinate the negotiation and maintenance of Quality Agreements with suppliers and internal stakeholders
Monitor and report on supplier performance metrics risks and trends to Senior Leadership
Ensure alignment of supplier master data in SAP and related systems across the network
Manage completion of audit observation responses in a timely and effective manner
Apply quality risk management principles across materials and supplier decisions
Drive or contribute to initiatives that enhance raw material and supplier lifecycle management
People management responsibilities may be required depending on team structure and business needs
Travel may be required up to 20%
Other responsibilities as required to support business priorities
Basic Qualifications
Bachelors degree and 8 years of relevant experience; OR
Masters degree and 6 years of relevant experience; OR
PhD and 2 years of relevant experience
Degree in science or engineering with relevant GMP experience
Proven track record of working with external suppliers in a regulated environment
At least 2 years of experience overseeing CDMOs or suppliers
Preferred Qualifications
Knowledge and working experience in some of the following areas:
Syringes (glass breakage investigations/certifications fractography)
Needles (defect investigations e.g. hooked bent and cracked needles)
Vials (delamination issues cracked vials developing reinspection processes understanding of manufacturing processes)
Stoppers (knowledge of coring particulate investigations)
Devices (manual needle guard issue resolution auto-injector issues component manufacturing)
Understanding of Quality Management Systems and regulatory requirements
Experience managing external suppliers and CDMOs with understanding of material categories commodity-specific risks and regulatory expectations
Hands-on involvement in supplier onboarding and qualification processes
Understanding of incoming inspection sampling strategies (AQLs) and certification protocols
Proficiency in SAP or similar ERP systems for supplier master data
Exposure to FDA inspections mock audits and quality systems assessments
Strong interpersonal and relationship management skills with the ability to tailor communication across functions and levels
Experience working cross-functionally with Quality Tech Ops Manufacturing and Supply Chain
Prior background in process development manufacturing or technical development is a plus
Proven ability to prioritize execute and adapt in a fast-paced and evolving environment
Self-starter who works well independently and as part of a collaborative team
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:
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:
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 disabilitygenetic 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 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 for assistance.
For more information about equal employment opportunity protections please view theKnow Your Rights poster.
NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT
YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT
PAY TRANSPARENCY NONDISCRIMINATION PROVISION
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.
For Current Gilead Employees and Contractors:
Please apply via the Internal Career Opportunities portal in Workday.
Required Experience:
Exec
Employment Type
Full-Time
