SUMMARY/JOB PURPOSE:
Responsible for assisting in the development, implementation and maintenance of QA systems and activities supporting GCP and PV operations. Provides assistance with planning and conducting audits of vendors and associated documentation activities.
Essential Duties And Responsibilities:
• Responsible for assisting in the development of internal processes and systems related to GCP and PV QA activities;
• Provides direct support to clinical study teams and participates in QA planning and implementation to support study operations;
• Participates in the development and approval for the CQA audit schedule including the contracting of PV and GCP audits to contractors and conducting complex audits;
• Responsible for developing, tracking and managing periodic management reports including key Clinical and PV Compliance and QA metrics;
• Participates in and support various development teams;
• Manages and/or participates in complex audits and regulatory inspections;
• Independently determines approach to complex compliance issues and reports findings to management with recommendations for resolution and verifies appropriate corrective actions and preventative actions (CAPAs) have been implemented and documented;
• Supports, trains staff and oversees GCP / PV consultants;
• Implements policies and/or procedures within CQA;
• Partners with other groups including Regulatory Affairs, Clinical Operations, Translational Medicine, regarding compliance issues and provides compliance guidance to all audited parties;
• Maintains knowledge of current regulation requirements and informs Clinical Development stakeholders of potential impact on the organization;
• Provides support during external audits and regulatory authority inspections;
• Participates in the development and delivery of GCP training internally;
• Represents CQA in internal presentations on quality issues, initiatives and projects.
Supervisory Responsibilities:
• None
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS: Education/Experience:
• BS/BA degree in related discipline and a minimum of nine years of related experience; or,
• MS/MA degree in related discipline and a minimum of seven years of related experience; or,
• PhD in related discipline and a minimum of two years of related experience; or,
• Equivalent combination of education and experience.
Experience/The Ideal for Successful Entry into Job:
• Typically requires a minimum six to eight (6-8) years of related CQA, GCP, PV experience, and/or combination of experience and education/training.
• At least 6+ years of progressive related experience
• Experience in the biotech or pharmaceutical industry is preferred.
Knowledge/Skills:
• Demonstrated knowledge of the drug development process
• Demonstrated audit conduct and management experience, particularly in GCP and PV disciplines is required.
• Working knowledge of supporting preparation and submission activities, specifically in relation to GCP and PV Quality, for global regulatory filings.
• Excellent verbal and written communication skills
• Ability to influence others as part of a collaborative team and negotiate effective solutions; strong interpersonal and social skills.
• Uses broad expertise or unique knowledge and skills to contribute to development of company objectives and principles, and to achieve goals in creative and effective ways.
• Develops technical solutions to complex problems.
• Identifies and implements methods, techniques, procedures and evaluation criteria to achieve results.
• Guides the successful completion of major programs, projects and/or functions.
• Interprets, executes and recommends modifications to companywide policies and/or divisional programs.
• Has complete understanding and wide application of technical principles, theories, concepts and techniques.
• Detailed oriented and committed to precision in execution of tasks and processes
• Has knowledge of other related disciplines.
• Must be proficient in Word, Exel, PowerPoint and Visio.
JOB COMPLEXITY:
• Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
• Able to multi-task (review and analyze study site and/or vendor audit reports and provide support to manage open CAPAs to closure).
• Works on complex issues where analysis of situations or data requires an in-depth knowledge of the clinical research and PV processes and corporate goals.
• Exercises independent judgment in methods, techniques and evaluation of criteria for obtaining results.
• Participates in corporate development of methods, techniques and evaluation criteria for projects, programs and people.
• Work with various CROs and team members to ensure Exelixis project/program goals are met.
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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 $140,000 - $199,000 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.