Director, Quality Operations

Cytokineticsis a specialty cardiovascular biopharmaceutical company building on its over 25 years of pioneering scientific innovations in muscle biology and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction.

Cytokinetics is seeking a highly motivated individual to join our team as Director of Quality Assurance with responsibility for oversight of Quality Control activities. You will have the opportunity to create and ensure quality processes and systems are optimized and carried out appropriately to support GMP development and commercial activities for our first product launch!

The Director QA will provide strategic leadership and QA oversight of all Quality Control (QC) generated data within the pharmaceutical manufacturing environment with a key focus on data integrity stability program governance and compliant product release. This is not a QC role but a QA leadership role to ensure that QC data management across internal and external (CMO) networks aligns with global regulatory expectations and corporate quality standards. The Director partners with Global Supply Chain and Technical Operations Analytical groups Regulatory Affairs and external testing sites to maintain the highest level of quality and data reliability supporting clinical and commercial products.

Responsibilities:

• Provide strategic leadership and quality governance for QC data oversight programs establishing standards to ensure global compliance accuracy and data integrity.

• Lead QA oversight for product stability and lot release programs ensuring alignment with cGMP FDA EMA and ICH expectations.

• Develop implement and continuously improve governance frameworks for analytical data review and trending across internal teams and CMOs.

• Direct QA review strategies for critical QC deliverables including analytical trends OOS and OOT investigations and product shelf-life assessments.

• Chair or co-lead cross-functional forums to ensure proactive identification and mitigation of analytical or stability risks.

• Provide final QA endorsement for CoAs to support product disposition decisions. Ensure robust processes are in place for review and approval by QA.

• Oversee QA partner engagement with CMOs and testing laboratories to ensure alignment with quality agreements stability plans and regulatory guidelines.

• Serve as subject matter leader in QA oversight of data review stability programs and batch release data with the potential opportunity to build and mentor a team as the function expands.

• Guide cross-functional teams in readiness for global regulatory inspections; act as primary QA representative and SME in data integrity and stability and batch release data compliance.

• Collaborate with Regulatory Affairs and Technical Operations to support CMC submissions and responses to health authority queries related to analytical data.

• Oversee monitoring and reporting of stability metrics and quality performance indicators to senior leadership.

• Lead continuous improvement initiatives to strengthen QA oversight processes and analytical data life-cycle management.

Minimum qualifications:

• Bachelors Degree in a scientific or technical discipline with 7 years experience in the biopharmaceutical or pharmaceutical industry with at least 5 years of experience within QA/QC. Advanced degree (MS PhD) is a plus.

• Ability to work in a collaborative team environment is essential.

• Experience with clinical/ commercial QC / stability programs.

• Knowledge of US and EU cGMPregulations/guidance.

• Ability to prioritize objectives from multiple projects adhere to scheduled timelines while maintaining flexibility and attention to detail.

• Effective communication skills both verbal and written.

• Must have strong analytical and interpersonal communication skills.

• Experience writing reviewing and editing SOPs and specifications.

• Experience using electronic Quality Management Systems is a plus.

• Knowledge of pharmaceutical regulations within the US (FDA) and Europe (EMA) required; additional knowledge of other ROW regulations a plus.

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Pay Range:

Our employees come from different backgrounds and we celebrate those differences. We are looking for the best candidates for our open roles but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team we would love to hear from you.

Please review ourGeneral Data Protection Regulation (GDPR) policyPRIOR to applying.

Our passion is anchored in robust scientific thinking grounded in integrity and critical thinking. We keep the patient front and center in all we do all actions and decisions are in service of the patient and their caregivers. We champion integrity ethics doing the right thing and being our best selves.

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Cytokinetics is an Equal Opportunity Employer