Job Description

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.Cytokinetics is seeking a highly motivated individual to join our team as Associate 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 Associate Director, QA will be responsible for oversight of Quality Control (QC) test data in a pharmaceutical manufacturing environment, with a principal focus on data associated with stability studies and lot release. This is NOT a QC role, but a QA leadership position dedicated to ensuring the accuracy, integrity, and compliance of all QC data, processes, and records. The role functions as a key partner with Global Supply Chain and Technical Operations Analytical groups, Regulatory Affairs, and other departments to ensure all testing and data management meet regulatory and company standards.Responsibilities:Provide QA oversight of QC-generated data, particularly for product stability and lot release, ensuring compliance with cGMP, FDA, EMA, and other relevant regulations.Collaborate closely with Technical Operations Analytical groups to ensure QC data that support stability and lot release are compliant with specifications and xxxOversee all aspects of QC data including review and approval of clinical and commercial stability products, which encompasses all starting materials, drug substance intermediates, drug substance, critical components, drug product intermediates, and drug products for a clinical and commercial programReview and approve:Stability protocolsOOS/OOT investigationsTrend reports and final summary reportsOversee timely data evaluation and escalations related to product shelf-life or specification trends.Support oversight of QC activities at CMOs including review of release and stability raw data, data quality, and adherence to timelines.Review and approve SOPs and quality documentation related to Quality Assurance, QC and stability.Oversee the generation, review, and approval of CoAs for Drug Substance, final product release and stability batches.Ensure CoAs:Accurately reflect analytical resultsComply with product specifications and regulatory filingsAre reviewed for completeness, traceability, and data integrityServes as QA representative in cross-functional working teams and/or working with outside vendors to meet stability needs.Support batch release decisions through QA review of CoAs and associated QC dataCollaborate with Technical Operations to ensure stability studies are initiated within project timelines and proactively monitor studies to ensure compliance with study protocols, quality agreements and regulatory commitmentsOversee the stability program and QC testing in accordance with Cytokinetics procedures and regulatory guidelines.Assist Technical Operations in the reviews of both internal and external (CMO) records, including stability test records/reports, protocols, change controls, deviations, and OOS.Assist in the preparation of CMC regulatory submissions.Authors, reviews, and/or approve data and trending reportsIdentifies areas for improvement and drives projects to implement solutions.Effectively communicate with internal and external stakeholdersMonitor, track and publish stability program metricsEnsure all records adhere to cGMP/GDP expectationsParticipate in project team meetings, Materials Review Board Meetings, and other meetings as applicableMaintain a thorough knowledge of appropriate standard operating procedures, and recommend/initiate SOP updates and improvements as appropriateParticipate in conducting internal and vendor auditsSupport regulatory agency inspections as requiredPerform other related duties as assigned from time to time based on company needs such as maintaining and managing all QA Ops GMP documents, controlled documents and quality records according to company policies and procedures.Minimum qualifications:Bachelor's 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/QCAbility to work in a collaborative team environment is essentialExperience with clinical/ commercial QC/ stability programs.Knowledge of US and EU cGMP regulations/guidance.Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detailEffective communication skills, both verbal and written.Must have strong analytical and interpersonal communication skillsExperience writing, reviewing and editing SOPs and specificationsExperience using electronic Quality Management Systems is a plusKnowledge of pharmaceutical regulations within the US (FDA) and Europe (EMA) required; additional knowledge of other ROW regulations a plus.#LI-HYBRIDPay Range:In the U.S., the hiring pay range for fully qualified candidates is $195,300 -$227,850 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.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 our General Data Protection Regulation (GDPR) policy PRIOR 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.Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and OffersRecently, there have been fraudulent employment offers being sent to candidates on behalf of Cytokinetics. Please be advised that all legitimate offers from Cytokinetics will come directly from our official email domain (Cytokinetics.com) and will only be made after completing a formal interview process.Here are some ways to check for authenticity:We do not conduct job interviews through non-standard text messaging applicationsWe will never request personal information such as banking details until after an official offer has been accepted and verifiedWe will never request that you purchase equipment or other items when interviewing or hiringIf you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at talentacquisition@cytokinetics.comPlease visit our website at: is an Equal Opportunity Employer

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