Exelixis, Inc.
Associate Director, Quality Systems (Finance)
The Associate Director is responsible for the development, implementation and maintenance of Quality Management Systems and activities. This role also manages Quality Management Systems, performance metrics and all Quality Systems supporting tools. This individual leads multi-disciplinary teams to identify and implement quality systems, including electronic tools.
Position Requirements
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Develops, establishes and maintains Quality Management Systems (Training, Document Control, Change Control, Deviation, CAPA, QSMR), procedures, supporting IT tools, and metrics to ensure QMS effectiveness and continuous improvement.
• Effectively utilizes Quality Risk Management principles
• Acts as a QA contact with QMS IT system vendors, and collaborates on contracts, validation activities, change management and other QA activities with internal IT business partner.
• Oversees the day to day execution of the document control process, training, deviation/CAPA, and internal change control processes.
• Ensures company's compliance with Title 21 CFR Part 11 QMS supporting tools- MasterControls, ComplianceWire, and similar systems
• Understands regulatory agency policies and guidance as it pertains to QA issues.
• Partners with internal stakeholders to ensure Quality Systems meet stakeholder needs as the GLP, GVP, GCP, GMP and GDP Quality System for Exelixis.
• Understands regulatory agency policies and guidance and translate it into Quality Systems applications.
• Provides direction to audit staff.
• Develops of work instructions and standard operating procedures for Quality Assurance and provides Quality oversight to SOP content developed by others.
• Develops and implements recurring operational review of the Quality Systems in formal Quality Systems Management Review processes
• Ability to travel up to 25% is expected for this position.
SUPERVISORY RESPONSIBILITIES:
• Directly supervises employee(s).
• Indirectly supervises employee(s) through a dotted line structure or via other subordinate supervisors.
• Supervision of contingent workforce and consultants in support of Quality Systems
EDUCATION/EXPERIENCE/SKILLS:
Education:
• BS/BA degree in related discipline and ten years of related experience; or,
• Equivalent combination of education and experience.
Experience:
• Typically requires a minimum ten (10) years of related QA experience, and/or combination of experience and education/training.
• Experience in the biotech or pharmaceutical industry is required.
• Previous experience supervising direct staff and or contract staff.
Knowledge/Skills/Abilities:
• Working knowledge of the commercial and clinical manufacturing GMP, GCP, GDP, GLP and Good Pharmacovigilance Practices Quality Systems requirements including the Federal laws and regulations affecting the pharmaceutical industry.
• Has extensive experience in relevant industry/profession including primary decision making.
• Ability to actively engage on the QA Leadership Team to ensure cross discipline objectives are met.
• 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.
• Attention to detail when utilizing PC or reviewing documents and editing/proof-reading documents.
• Has extensive knowledge of other related disciplines.
• Applies strong analytical and business communication skills.
• Excellent verbal and written communication skills.
• Must be proficient in Word, Exel and PowerPoint. ComplianceWire, Master Controls and/or LiveLink experience is a plus
JOB COMPLEXITY:
• Works on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
• Able to multi-task and work cross-functionally.
• Works on complex issues where analysis of situations or data requires an in-depth knowledge of the Quality Systems processes.
• 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 Contract Organizations and team members to ensure Exelixis project/program goals are met.
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.