Vice President, Quality Assurance at Aimmune Therapeutics, Inc in Brisbane, CA

Summary:

The position is responsible for providing the leadership and management of all GXP quality assurance and other Quality executive leadership activities at the company.

Specific Responsibilities:

• Continue to develop, implement, maintain, and communicate the corporate quality strategy, quality plan and quality programs throughout the Company
• Provide leadership in ensuring continuous compliance with all applicable internal and external regulations, standards, policies, and procedures related to the quality, regulatory status, and performance of company GxP operations, processes and development and commercial products
• Ensure the Company is kept current with all new quality-related regulatory requires and provide guidance to senior management on the implications of any new or updated requirements
• Maintain a quality management system by directing, and providing oversight and input into the relevant quality systems and standards Including: batch release and control; change control; document management system; quality procedures, standards, and policies; audits; product complaints and recalls; quality system reporting; investigations and CAPAs; GxP training; and other related areas
• Ensure that the appropriate review and approval of Master Batch Records, Executed Batch Records, SOPs, Change Control Documentation, Product Labeling and Revisions, Audit Reports, Validation Documentation, Product Specifications, Analytical Methods, and Contractor Qualifications are executed
• Direct all inspection readiness activities
• Coordinate activities and lead interactions during regulatory agency inspections
• Direct the qualification, auditing, and compliance oversight of Contractors
• Develop, track, and trend the Quality Metrics for contractor performance and product quality
• Establish Quality Agreements with vendor partners
• Provide feedback to operational department heads regarding audits, plans, findings, CAPAs, and issue resolution
• Lead and direct QA staff for any quality support of global regulatory submissions as required
• Act as the quality subject matter expert (SME) for new or existing products, processes, techniques, procedures or facilities/equipment to ensure compliance with GXP
• Prepare and review QA budget
• Support the Company’s project teams and assist with project scheduling to assure that timelines and deadlines are met in the most efficient and economical manner while maintaining adheres to GxP
• Provide regular updates and recommendations to the Executive Committee as requested regarding the status of objectives, projects and goals relative to quality compliance objectives
• Hire, manage, support, develop/train QA staff and consultants and secure sufficient resources to support the company’s goals and objectives
• Serve as a subject matter to guide the company on QA & Regulatory Compliance related issues by communicating actively and effectively with the SVP, Technical Operations and Regulatory
• Maintain a performance and improvement culture
• Domestic and international travel required

Pivotal experience and expertise:

• Quality Functional Expertise – Established expertise in GxP systems, with extensive knowledge of global regulations and standards as well as QMS implementation success
• CMO Relationship Management – Experience managing all quality aspects of a global biologics manufacturing network of contract manufacturers
• Development and Commercial Product Quality Management – Expertise in co-managing all aspects of both development product as well as commercial product quality oversight
• Tech Ops Savvy – Experience and influence beyond Quality in complementary disciplines of Supply Chain and Technical Operations
• Risk-Based Quality Experience – Proven success anticipating industry trends and regulatory requirements to manage business risk, compliance, and sustainability

Preferred Qualifications / Requirements:

• BS Degree in related area. Advanced degree preferred.
• 15+ years of experience in the biotechnology/pharmaceutical industry
• Minimum of 8 years’ senior quality systems leadership in the bio/pharma industry, including the oversight of commercial products
• High level of familiarity with broad range of compliance areas and ability to assess risk and develop solutions
• Ability to build and manage relationships with business partners
• Advanced knowledge of Quality Assurance principles, concepts, industry practices and standards
• Strong proven hands-on experiences with GLP, GMP, GCP compliance matters and contractor management in the bio/pharma industry
• Previous experience with building QA systems and company-wide SOP systems for all phases of clinical Development
• Strong knowledge of US and other major global (ICH, EU) regulatory compliance requirements
• Extensive experience handling government regulatory inspection required
• Provided ability to interpret regulations, to define and communicate strategy/plan to teams across multiple programs
• Experience with nonclinical, clinical and CMC aspects of the product development
• Understanding of scientific methods and the ability to interpret and communicate scientific data internally and externally
• Must be able to effectively collaborate with peers and comfortable working in a matrixed team
• Excellent project management and organization skills
• Excellent communication skills and interpersonal skills
• Knowledge of IT systems and electronic quality management systems
• Proficiency with eCTD software, document management systems, review management/version control software, Microsoft Office and Adobe Acrobat
• Excellent communication skills
• Attention to detail
• Ability to work under deadline pressure, and to effectively manage multiple projects and rapidly shifting priorities
• Solution orientated with analytical thinking and problem-solving skills
• Ability to multi-task in a very fast-paced environment

Aimmune Therapeutics, Inc., a Nestlé Health Science Company, is a biopharmaceutical company developing and commercializing treatments for potentially life-threatening food allergies. The Company’s Characterized Oral Desensitization ImmunoTherapy (CODIT™) approach is intended to provide meaningful levels of protection against allergic reactions resulting from accidental exposure to food allergens by desensitizing patients with defined, precise amounts of key allergens.