{"id":1317499,"url":"https://alion.io/job/cytokinetics-director-quality-systems","title":"Director, Quality Systems","company":{"id":1919595,"name":"Cytokinetics","domain":"cytokinetics.com","url":"https://alion.io/company/cytokinetics","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":75,"open_postings":12,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-01T05:45:00Z"}},"role":"Science & Research","role_family":"Science & Research","seniority":"head","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["South San Francisco, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":225000,"max":262500,"currency":"USD","period":"year","gross":null,"usd_annual":262500},"salary_estimate":null,"experience_years_min":12,"visa_sponsorship":false,"relocation_package":false,"has_equity":true,"technologies":[{"name":"GDPR","optional":false}],"status":"live","first_seen_at":"2026-09-23T00:00:00Z","employer_posted_date":"2026-09-23","last_verified_at":"2026-10-01T17:18:11Z","board_verified":true,"closed_at":null,"days_open":9,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":9},"description":"Cytokinetics is 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.\nThe Director of Quality Systems will be responsible for the overall operation of Cytokinetics Quality Systems and will provide leadership for the quality management system, document control, and GxP training groups. This role will provide strategic direction, leadership, and development for these groups to ensure that all aspects of pharmaceutical quality management systems (QMS), controlled documentation, and training programs are effectively established, implemented, and maintained in accordance with cGMP regulations and industry best practices. The Director of Quality Systems will serve as a key advisor on QMS-related matters and ensure quality system processes support business objectives, regulatory compliance, and inspection readiness.\nResponsibilities\nProvide strategic roadmap for the Quality Systems organization, including oversight of quality management system, document control, and GxP training groups, oversee personnel performance management, mentoring, and career development.\nLead and develop teams responsible for document control, GxP training administration, and quality system processes, ensuring effective execution and continuous improvement.\nActs as Business Process Owner of the QMS.\nEnsure Quality Systems and processes are maintained and modified regularly to ensure best practices.\nEnsure Quality Systems support compliance with applicable FDA, EMA, ICH, GxP, and other relevant regulatory requirements.\nOversee the document control program, ensuring the effective management, review, approval, issuance, revision, archival, and retrieval of GxP documents and records.\nOversee the GxP training program, ensuring training curricula, assignment, completion, effectiveness, and compliance requirements are met across the company.\nCollaborate with IT to implement updates/enhancements to the eQMS and ensure effective system support.\nLead company-wide quality systems projects across various departments.\nWork with GxP functional leaders to implement processes and systems that enable the business to operate effectively. Provide process analytics and oversight on a continuous basis to enforce requirements and meet regulations.\nMonitor the entire quality system to ensure that acceptable levels of performance are maintained.\nManage continuous improvement project as required.\nEstablish and report on appropriate metrics and dashboards to monitor overall quality system health and facilitate quality review board and management review.\nReview and approve cGMP records and documents as required.\nDevelop and manage goals and corresponding budget in alignment with company vision and goals.\nWork on complex problems that may have implications across functions, apply strong judgment in resolving problems and make recommendations.\nLead inspection readiness activities related to Quality Systems.\nLead, mentor, and develop Quality Systems personnel and functional subject matter experts.\nRecruit talent and build a high performing team, mentor, and coach colleagues.\n Qualifications\nBachelor's degree in life sciences with 12+ years’ experience in the biopharmaceutical industry, including at least 7 years of experience leading Quality Systems within the pharmaceutical, biotechnology, medical device, or other regulated life sciences industry.\n5+ years of progressive people-management experience including leading, mentoring, and developing Quality professionals.\nDemonstrated leadership with effective communication skills and an ability to deliver results through teamwork.\nStrong direct experience with Quality Management Systems, including CAPA, Change Control, Deviations, Continuous Improvements and Quality Risk Management.\nVeeva Quality Vault experience preferred.\nMust think critically and be able to make decisions independently, determine appropriate resources for problem resolution, and have strong organizational and planning skills.\nIn-depth knowledge of Quality principles, concepts, industry practices, and standards.\nDemonstrated ability to execute strategic and tactical objectives provided by senior leaders both within and outside of Quality.\nAble to effectively communicate vision and expectations to the teams.\nExperience in a global, multi-site, or international GxP environment preferred. #LI-HYBRID\nPay Range:\nThe expected salary range for this position based on the primary location of South San Francisco, CA is $225,000 - $262,500. The base pay offered will take into account internal equity and may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. Base salary is just one component of our competitive total compensation package, which includes equity in the form of stock options and/or restricted stock units, comprehensive health, dental, vision, life and disability insurance coverage, 401k retirement benefits with employer match, learning and wellness stipends, and paid time off. Note that benefits are subject to change and may vary based on jurisdiction of employment.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.\nPlease review our General Data Protection Regulation (GDPR) policy PRIOR to applying.\nOur 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.\nFraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers\nRecently, 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.\nHere are some ways to check for authenticity:\nWe do not conduct job interviews through non-standard text messaging applications\n\nWe will never request personal information such as banking details until after an official offer has been accepted and verified\n\nWe will never request that you purchase equipment or other items when interviewing or hiring\n\nIf you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at \n\nPlease visit our website at: www.cytokinetics.com\nCytokinetics is an Equal Opportunity Employer","description_format":"text","description_chars":7055,"description_truncated":false,"requirements":{"experience_years_min":12,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan","Equity","Insurance coverage","Restricted stock units","Stock options"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care","Biologics & Biosimilars"],"lifecycle":[{"event":"open","at":"2026-09-26T19:55:28Z"}],"liveness":{"score":56,"band":"ok","label":"Likely open","p_open":0.9,"p_active":0.621,"p_room":1,"age_days":8,"expected_fill_days":27,"reasons":["conf:79","stale_co","urgency","win:early"],"computed_at":"2026-10-01T05:45:00Z"},"pay":{"stated_usd_annual":262500,"is_top_pay":false},"html_url":"https://alion.io/job/cytokinetics-director-quality-systems","json_url":"https://alion.io/job/cytokinetics-director-quality-systems.json","meta":{"generated_at":"2026-10-02T01:43:55Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","usage":{"tier":"crawler","counted_by":"address","units_charged":1,"used_today":2239,"day_limit":5000,"remaining_today":2761,"minute_limit":60,"resets_at":"2026-10-03T00:00:00Z"}}}