Senior Director, GCP, GVP, GLP QA

SUMMARY/JOB PURPOSE:The Senior Director, GCP/PV/GLP QA is accountable and responsible for defining and implementing strategy and leading a team to ensure QA compliance across GCP, PV and GLP functions, systems and activities. Integrates Quality throughout all the GCP process, audits using a risk-based approach, implements Quality Risk Management (QRM), tracks and trends key metrics, and ensures clinical data integrity. Identifies and drives continuous improvement, partnering with Product Development, Clinical Development, Clinical Supply Chain, project teams, Medical Affairs and Regulatory. Strong partner with internal and external partners to resolve issues for continuous improvement. Aligns key QA strategies with business goals and understands the global regulatory compliance landscape.Represents QA as the QA Partner (Primary Point of Contact), speaking One Voice for Quality, for Exelixis business stakeholders, and represents QA in an outwardly and business-facing capacity, in strategic and decision forums, and triages communication between Exelixis business functions internally or externally and QA, to provide and ensure delivery on company core goals and pipeline deliverables.ESSENTIAL DUTIES AND RESPONSIBILITIES:Establishes and maintain the GCP/PV/GLP QA programs, policies and procedures; ensure compliance of the non-clinical and clinical trials to applicable health authority regulations and guidelines.Act as the primary business partner to Product Development and provide guidance to ensure data integrity and appropriate risk management.Partner with Audits and use Quality Risk Management (QRM) to determine which sites to audit, frequency, and track and trend findings to ensure compliant conduct of Exelixis Sponsored clinical trials.Participate in inspection management, mock inspections, vendor audits, and Health Authorities inspections.Understand and interpret regulatory agency policies and guidances.Accountable for QA review of non-clinical and clinical trial documentation, and documents submitted to regulatory agencies.Author, review, and approve Quality documents.Monitor current and projected quality issues, escalate and drive for rapid resolution on events of significance for Exelixis' business interests.QA Partner for Exelixis business stakeholders, in an outwardly and business-facing capacity, in strategic and decision forums, and triage communication between Exelixis business functions and QA to ensure delivery on company core goals and pipeline deliverables. Develops QA strategy for own area aligned with business needs; manages complex issues, escalates rapidly and drives for resolution.Provide guidance, coaching and development to QA Core.SUPERVISORY RESPONSIBILITIES:Leads a team of quality professionals.Leads a cross functional team if required.EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:Education/Experience:BS/BA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and a minimum of fifteen years of related experience; or,MS/MA degree in Biology, Computer Science, Education, Learning & Development, Sciences, or related discipline and a minimum of thirteen years of related experience; or,PhD in related discipline and a minimum of twelve years of related experience; or,Equivalent combination of education and experience.Experience/The Ideal for Successful Entry into Job:Typically requires a minimum of 22 years' experience in applicable industry (biotech, pharmaceutical or related).Typically requires a minimum of 10 years of people management at various levels of the management (direct or indirect).Demonstrated knowledge of cGxP (GCP, PV, GLP), drug development and applicable Global Regulatory Requirements and regulations.Uses broad expertise or unique knowledge and skills to develop company objectives and principles, achieving goals with measurable impact and outcomes.Excellent written, oral and presentation communication skills, able to translate complex concepts across all levels of the organization.Applies strong analytical thinking to develop technical and/or business solutions to complex problems. Drives for results.Identifies and implements methods, techniques, procedures, and evaluation criteria to achieve results.Ensures successful completion of major programs, projects and/or functions.Hires strong staff, provides training and guidance to deliver results on company core deliverables, and meet metrics.Interprets, executes, and recommends modifications or additions to company policies and/or divisional programs. May establish organizational policies in a major segment of the company.Has complete understanding and wide application of technical principles, theories, concepts, and techniques.Proven leadership, organizational and management skills to coordinate multi-discipline groups, ability to manage complex issues, sound decision-making, and strategic planning skills.International/global experience preferred.Experience in auditing is required.Knowledge/Skills:Applies extensive knowledge of biotechnology/pharmaceutical sector to perform complex work, demonstrates influence beyond the QA function and makes decisions on highly complex issues.Excellent organizational agility; gets results while strengthening internal and external relationships.Excellent organizational and planning skills; analyzes and improves processes to achieve high quality work.Establishes high performance standards and clear responsibilities to meet individual and team objectives.Excellent communication skills in a range of media; inspires engagement to facilitate critical discussions.Creates a collaborative atmosphere of mutual trust, to achieve alignment and deliver on common goals.Effectively manages conflict.Models team spirit, culture, and ethics, builds and empowers high-performing team.Sets measurable team goals, builds team member's capabilities, promotes career development, and develops team succession plans.Proven leader with demonstrated ability to build and lead successful teams, through ambiguity and change.Strong collaboration skills, demonstrated ability to lead through change and identify opportunities that result in positive business outcomes.JOB COMPLEXITY:This role is critical to the success of the company core deliverables and requires continuous communication to maintain alignment across the organization.This role requires management of multiple competing priorities, and the ability to evaluate data to detect weak signals, blind spots and escalate cumulative risks.Plans and executes multiple tasks, considering alternative methods and contingency plans to avoid potential issues and promote efficiency.Designs and implements solutions to address cross functional challenges, taking into consideration the broader impact.Engages, influences, and collaborates with stakeholders on cross-functional projects of increased corporate importance.WORKING CONDITIONS:This position is an onsite position.Some travel (either domestic or international) may be required (10-15%).#LI-CW1If 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 $209,000 - $297,000 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.DISCLAIMERThe 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.

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