Director, Capability Manager for Quality and Compliance Systems
Director, Capability Manager for Quality and Compliance Systems
United States - California - Foster City
Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gileads therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.
Making an impact on a global scale
Inclusion is one of the companys five core values. Thats because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.
When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company\'s mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North, South and Central America, Europe, Africa, Asia and Australia. Gilead makes it a priority to increase access to its medicines for people who can benefit from them, regardless of where they live or their economic status. This is the focus of the Access Operations & Emerging Markets business unit, spanning more than 130 resource-limited, low, lower-middle and upper-middle income countries across Latin America, Africa and Asia.
Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually, and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.
Specific Responsibilities and Skills
The Director, Capability Manager for Quality and Compliance Systems is responsible for the ideation, planning, development oversight of one or more of one or more information technology capabilities across multiple Gilead businesses. Participates in short and long-term business or IT strategic planning sessions, identifying opportunities and making recommendations for the enablement of system capabilities. Leads the analysis efforts for business case development, including resource estimates, prioritization and categorization. Advises on options, risks, costs versus benefits, and impacts on end-user, processes and system priorities. Collaborates with functional stakeholders and technical resources to cultivate technology solution in alignment with business or IT strategies. Establishes and maintains a strategic relationship with functional level stakeholders. Establishes and maintains a strategic relationship with functional level stakeholders.
- Cultivates and demonstrates an in-depth knowledge of Quality and Compliance business
- and IT capability
- Participates in short- and long-term strategic planning session to improve business or IT
- processes through capability development
- Analyzes business or IT operations to understand their strengths and weaknesses to
- determine opportunities for improvements through capability enablement
- Demonstrates how capability enablement can assist departments/business areas and
- how platforms and solutions can support the achievement of short- and long-term
- business or IT capability goals
- Establishes and maintains a strategic relationship with functional level stakeholders
- Development of use cases, cost structure, and ROI model in support of investment
- projects and activities demonstrating clarity on how solution provides business value
- Actively communicates with business, IT and other stakeholders, to ensure awareness of
- vision, roadmap, progress, risks, and results associated with a key capability
- Works with appropriate stakeholders to proactively identify and evaluate risks
- associated with business decisions that may impact a capability enablement
- Participates in incremental planning and defines release intervals
- Works with functional stakeholders and technical resources to cultivate appropriate
- solution required to meet business or IT objectives
- Engages Domain Architecture team to align long-term technology strategy with business
- Ensures capability expectations are set and identifies and resolves disconnects through
- negotiation or governance mechanisms
- Analyzes technology trends to determine impact to the capability and benefit realization
- Communicates to other IT domains for awareness of key capability aspects, how they
- operate and how they are impacted
Leadership & Management
- Manages and prioritizes the flow of work in program backlog
- Fosters a team environment and mentors members of IT team
Associates Degree and Fourteen Years Experience OR Bachelor\'s Degree and Twelve Years' Experience OR Masters\' Degree and Ten Years' Experience OR PhD and Eight Years' Experience
Knowledge, Experience and Skills:
- Good understanding of GxP compliance and 21 CFR Part 11 requirements
- 7+ years experience in managing Quality and Compliance related IT
- Demonstrates an in-depth knowledge of IT and the service catalog and assigned departments/business areas
- Strong communication, excellent research skills, and learning agility to understand internal business or IT process, best practices and translate into technology needs/opportunities
- Strong work ethic, a sense of business urgency, and ability to work effectively with many deadlines in a complex matrix organization
- Strong business acumen
- Possesses strong leadership skills and able to make critical decisions
- Ability to find innovative ways to resolve problems
- Strong executive-level verbal and written communications
- Extensive experience in stakeholder management, dealing with senior management up to executive level
- Ability to work with dispersed and global teams and locations
- Excellent at interpersonal skills and relationship development
- Specific experience in the Life Sciences/Pharma/Medical Devices/Healthcare industries is preferred
- Functional domain expertise in Drug development functional areas and/or Pharmaceutical Ops/Pharma development and manufacturing areas
Gilead Core Values:
- Integrity (Doing What's Right)
- Inclusion (Encouraging Diversity)
- Teamwork (Working Together)
- Excellence (Being Your Best)
- Accountability (Taking Personal Responsibility)
For jobs in the United States:
As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, 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 firstname.lastname@example.org for assistance.
Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S. employees and contractors to receive the COVID-19 vaccines as a condition of employment. Full vaccination is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.\u200b
For more information about equal employment opportunity protections, please view the EEO is the Law' 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 log onto your Internal Career Site to apply for this job.
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