Senior Manager, Quality at Exelixis, Inc. in Alameda, California

Job Description:

Company Description

Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.

As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we're seeking to add talented, dedicated employees to power our mission.

Cancer is our cause. Make it yours, too.

Job Description

Exelixis has newly formed the Digital Transformation (DT) function to effectively support Exelixis' rapid growth which is expected in the next 3 to 5 years. To support business functions in process simplification, automation and data-driven decision making, DT will introduce relevant technology products. DT products will aid in sustaining both organic and inorganic growth of Exelixis, increasing operational complexity of additional product launches, indications, capabilities, and geographies. Senior Manager - Quality will focus on product design, development and maturity in close collaboration with business partners from Quality functions in simplifying the business processes, enhance digital dexterity of the functions, establish what success looks like for the users of Quality applications across the enterprise.

Qualifications

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• General responsibilities for this position will include (but are not limited to) the following:
o Partner with Implementation Vendor to ensure the effective execution of the projects and services, holding them accountable to project scope, SLAs and KPIs.
o Partner with stakeholders in the Quality function to capture, analyze and document functional requirements Specifications
o Translate business requirement to functional requirements and communicate them to technical teams
o Create/update and review system related documents including validation deliverables
o Work as the primary technical and delivery lead within the Quality systems (QMS), UL (Compliance wire - LMS), QDMS.
• Product owner and on-site escalation point for technical issues related to Quality systems.
• Participates in business customer idea elaboration and technical problem-solving with potential technical options including proposals, front-end studies, development plans, and presentations, as directed in a consulting role
• Accountable for working with Business Process Owner and QA (for validated systems) to identify the appropriate System Life Cycle model based on applicable regulatory requirements before presenting estimates for input to new system business case or change implementation plans
• Owns the delivery of the overall technical workstream or one or more technical modules of the project under development by leading and managing the technical delivery team Understands the end-to-end technical architecture for the solution being developed. Acts as a point of technical escalation and resolution during the project lifecycle as it relates to technical decisions
• Partners with Project Managers / Scrum Masters to develop the technical delivery work plan and schedule and ensures the appropriate technical delivery of business capabilities.
• Compliance (for non-GxP systems) or Validation Lead (for validated systems or qualified infrastructure) to ensure that the project plan reflects the dependencies and required deliverables of the selected System Life Cycle model
• Partners with Quality Assurance (QA), IT Compliance and Validation resources to consult and review test plans and validation plans and ensure that issues are properly assigned, fixed, and regressed

SUPERVISORY RESPONSIBILITIES:
• Supervises staff, including hiring, scheduling and assigning work, reviewing performance, and
recommends salary increases, promotions, transfers, demotions, or terminations.
• Manages others through subordinate supervisors.
• Directing work only (no direct reports, but directing work to a CMO, Consultant or 3rd party.)

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
This section lists the required level of job knowledge (such as education, experience, knowledge, skills, and abilities) required to do the job. This section focuses on the "minimum" level of qualifications for an individual to be productive and successful in this role.

Education:
• Bachelor's degree in related discipline + 7 years of related experience; or
• Master's degree in related discipline and 5 years of related experience; or
• PhD degree in related discipline and 5 years of related experience; or
• Equivalent combination of education and experience.

Experience/The Ideal Candidate will have:
• Typically requires a minimum of 7 years of related experience or the equivalent combination of experience and education/training.
• Experience is required in the areas of technology strategy, product design, engineering, platforms, data architecture, and analytics.
• Experience in Biotech/Pharma with emphasis on Research, Development and Pharma Ops areas.
• Experience with Agile, Scrum methodologies and DevOps. Cloud certifications is a plus.
• Experience working on various Pharmaceutical Quality systems like Trackwise, IQVIA - SmartSolve, Veeva QMS, Veeva Vault, Documentum, OpenText, Veeva QDMS, LMS - Compliance wire, Veeva LMS etc.
• Experience working with Computer System Validation in a GxP regulated area
• Strong Delivery skills, ability to work in a complex environment and an ability to influence cross-functional teams
• Experience working with SaaS applications and monitoring service levels and deployment schedules
• Experience managing a large group of consultants for delivery and sustainment and ensuring the quality of deliverables
• Strong Listener: Be able to patiently listen to understand the business needs
• Bachelor's degree in IT, CS, Business Process Management or related discipline or an equivalent number of years of work experience

Knowledge/Skills:
• Thorough understanding and high domain expertise of Quality processes, tools and industry benchmarking data.
• Demonstrated ability to participate with business in launching technologies to support drug launches, deliver large, complex, programs involving system and process reengineering and integration.
• Proven ability to collaborate with senior functional leaders to set vision, drive innovation and facilitate transformation to meet evolving business needs and priorities.
• Applies strong analytical and business communication skills.

WORKING CONDITIONS:
Identify the working conditions and physical demands that relate directly to the essential job duties and
responsibilities to be compliant with the Americans with Disabilities Act. Describe the type, intensity
(how much), frequency (how often), and duration (how long) of physical or mental capabilities
required. Consider the following:

Facilities/Alameda:
• Environment: primarily working indoors and outdoors of buildings
• Essential physical requirements, such as standing, stooping, or typing.
• Physical effort/lifting, such as sedentary - up to 10 pounds; light - up to 20 pounds; medium - up
to 50 pounds; heavy - over 50 pounds.
• Indicate if required to work weekends, nights, or be on-call as a regular part of the job.

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Additional Information

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.