SUMMARY/JOB PURPOSE:
This key role drives consistency across QA systems and processes for the Clinical QA team, identifying issues and risks, escalating in a timely fashion, and aligning metrics that provide input into a compliance scorecard for Clinical programs. This leader provides insight and partners with both GCP QA staff and Clinical Operations Quality Management (OQM) to address day-to-day clinical trial operations activities focused on deviations, investigations, audit findings and CAPAs. This role operates across all the Clinical project teams and provides training with inspection readiness activities as required.
Essential Duties And Responsibilities:
Responsible for designing and coordinating a comprehensive view and aligning standards on Quality systems across Clinical Quality Assurance.
Assesses current state, identifies gaps, develops an action plan, implements improvements, and monitors the Quality Systems and internal processes related to GCP QA activities
Develops, tracks, and manages periodic management reports focused on track and trend data for key Clinical and QA metrics driving the quality health of the GCP activities.
Reviews and approves Deviations, and Corrective and Preventive Actions (CAPAs)
Partners with other groups including Regulatory Affairs, Clinical Operations, Translational Medicine, regarding compliance issues and provides compliance guidance
Maintains knowledge of current Health Authority regulations and standards and informs Clinical Development stakeholders of potential impact on the organization
Represents CQA in internal presentations on quality issues, initiatives, and projects
Identifies issues and risks and proposes options and solutions, escalating risks in a timely manner.
Participates in identifying and implementing process and system improvements
Supervisory Responsibilities:
None
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
Bachelor's degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 11 years of relevant experience; or,
Master’s degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 9 years of relevant experience; or,
PhD degree in science (e.g., biology, chemistry, pharmacy, medical, mathematics, engineering, or a related field) and a minimum of 5 years of relevant experience; or,
Equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job:
Minimum of 10 years relevant experience in pharmaceutical and biotech industries.
Experience in Good Clinical Practices highly desired
Demonstrated experience in Quality Systems including critical analysis of impact and continuous improvement processes
Strong understanding of Quality Risk Management
Experience using standard MS Office
Knowledge/Skills:
Understanding of the drug development process, particularly related to QA oversight of clinical trials
Experience in assisting in the development of business strategies, metrics, and continuous improvements
Working knowledge of Health Authority rules and regulations
Proven ability to manage Quality Systems, assuring completeness and acceptability as defined for GCP.
Ability to apply Quality Risk Management in a variety of situations across Quality Systems
Ability to influence others as part of a collaborative team and negotiate effective solutions
Strong interpersonal and social skills
Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results.
Detail-oriented in execution of tasks and processes
Implements technical solutions within quality requirements to complex problems.
Excellent verbal and written communication skills
Exercises judgment within defined procedures and practices to determine appropriate action.
Provides insight and analysis of situations or data requires a review of a variety of factors.
Working Conditions:
Environment: primarily working in laboratories or in office
Infrequent travel may be required.
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If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!
Our compensation reflects the cost of labor across several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $177,500 - $251,500 annually. The base pay range may take into account the candidate’s geographic region, which will adjust the pay depending on the specific work location. The base pay offered will take into account the candidate’s geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.
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.