Senior Director, Quality Assurance Operations

Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.

Reporting to the Vice President of Quality (GXP), the Senior Director, Quality Assurance Operations will lead the strategy for GMP QA Operations for Cytokinetics and is accountable for the execution and administration of the QA program to support CMC operations in accordance with FDA, ICH, EMA regulations and guidelines and industry standards. This role will lead a QA team that is accountable for all aspects of product quality throughout the product lifecycle, both internally and in collaboration with CMOs and testing laboratories. This role will be responsible for QA related activities for clinical and commercial products including transition from development (Phase III) into commercial launch. This role is accountable for QA oversight of analytical testing, analytical method transfer and validation, process validation, and batch record review and batch disposition. The ideal candidate will have extensive experience leading GMP quality assurance activities and deep understanding and demonstrated working knowledge of CFRs, ICH guidance documents, and other regulations that govern GMP compliance during clinical development and commercialization of small molecule drug product. 

Responsibilities:

Full strategic responsibility for the GMP QA Operations team, including but not limited to, the following:

• Responsible for performance management, coaching and development of a team of approximately 10 personnel, and spearheading quality improvements of QA Operations
• Accountable for the multiple functions within QA Operations, QA process validation, analytical oversight, oversight of supplier performance and quality, batch records review, and batch disposition
• Strong partnership with Global Supply Chain and Technical Operations during development phases through commercialization
• Partner with Head of Quality EU / Qualified Person to a consistent global strategy and approach to ensure processes and documents are available to support QP batch certification
• Lead a team that is accountable for GMP QA Operations activities
• Facilitate review and approval of specifications, quality system records (change controls, deviations, CAPAs), technical reports
• Ensure adequate onsite person-in-the-plant support during manufacturing campaigns 
• Evaluate and identify gaps in Cytokinetics programs, develop remediation plans for full compliance
• Coordinate or oversee project activities within span of control
• Develop and maintain KPIs and data to measure effective operation of your team, your supplier performance, and span of control
• Communicate effectively and build cooperative and supportive working relationships with cross-functional teams, CMOs, and other suppliers
• Lead in the preparation of the team budget and be accountable for in-budget execution of projects
• Collaborate with other Quality Leadership Team members to identify continuous improvements, recommend appropriate actions, and execute team deliverables
• Author and review technical reports, as well as regulatory related documentation (i.e., INDs, IMPDs, NDAs, MAAs)

Qualifications

• BS degree in Pharmacy, Biology, Chemistry, Life Science, or equivalent with 15+ years of experience in pharmaceutical industry in quality assurance or in combination with manufacturing, with 12+ years in leadership positions
• Proven experience overseeing or leading a QA Operations organization
• Strong experience and technical knowledge in small molecule manufacturing, packaging, and labeling
• Direct experience with management of CMOs
• Experience building and leading teams, including management of direct reports
• In depth knowledge of cGMP regulations and compliance
• Robust understanding and knowledge of quality assurance concepts, investigations, and process improvements
• Strong written and verbal communication skills
• Strong organizational skills and ability to effectively manage multiple priorities and ambiguity
• Ability to travel domestically and internationally as needed

Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience, as well as the service line and l