New · posted Oct 15
Cytokinetics · Pharmaceuticals
Director, Clinical Quality Assurance
- South San Francisco, CA
- Hybrid
- Full-time
- Director
Open until filled
The role
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.
The Director, Clinical Quality Assurance (CQA) will be responsible for managing and overseeing global clinical quality strategy for clinical development programs. The role will lead the effort to establish, maintain, and ensure effectiveness of quality programs and documentation to assure compliance in an international regulatory environment. You will lead the CQA group’s effort for development and execution of quality plans, policies, procedures, and quality system elements in support of clinical programs. The Director, CQA will provide guidance on CQA related matters.
What you need
- Bachelor's degree in life sciences with 12+ years experience in a GCP related discipline
- Current and strong working knowledge, interpretation/implementation United States Code of Federal Regulations and European regulations and guidance, including ICH-GCP Guidance requirements governing clinical research conduct and pharmacovigilance operations
- Experience managing and developing staff
- Able to develop innovative solutions to issues and apply critical thinking to problem solving
- Able to organize and prioritize projects and CQA activities based on risk
- Able to effectively communicate vision and expectations to the teams
- Up to 10% travel may be required
What you'll do
- Lead and implement GCP QA strategy, manage and develop Clinical QA staff to support and enhance quality improvement initiatives for development programs
- Lead and implement overall GCP strategy, performance metrics, quality tolerance limits, and analytics reports
- Proactively streamline and strengthen clinical QA processes across the organization and implement improvements in collaboration with cross-functional teams
- Lead and ensure inspection readiness activities for internal and external entities
- Lead and/or co-host regulatory inspections
- Lead and oversee CQA’s vendor compliance oversight program and maintenance of GCP Quality Agreements
- Lead and manage a risk-based audit program and maintain audit metrics
- Manage and support internal audits of GCP processes, and quality audits of clinical vendors and investigator sites
- Ensure CQA participation on study teams to provide GCP compliance guidance and oversight to cross-functional stakeholders to ensure adherence to FDA & global regulatory requirements
- Identify compliance gaps and provide remediation recommendations for continuous improvement
- Review and approve SOPs, audit reports, quality event records as required
- Create, maintain, and adhere to department operating budget
Pay and benefits
$222,480 – $259,560 a year
Employer providedThe expected salary range for this position based on the primary location of South San Francisco, CA is $222,480 - $259,560. 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.
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.
Stock options and/or restricted stock units
Health, dental, vision, life and disability insurance
401k with employer match
Learning and wellness stipends
Paid time off
Where you'll work
South San Francisco, CAHybridOpen in Maps (opens in a new tab)
More jobs in South San Francisco, CAEqual opportunity, accessibility and legal noticesCytokinetics's statements, word for word
Fraud Warning: How to Identify Impersonated Cytokinetics Job Postings and Offers
Recently, 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 applications
We will never request personal information such as banking details until after an official offer has been accepted and verified
We will never request that you purchase equipment or other items when interviewing or hiring
If you are unsure about the authenticity of an offer, or if you receive any suspicious communication, please contact us directly at [email protected]
Job intelligence
The context around this role
Live data · October 15, 2026
Salary intelligence
How the pay compares
This role's midpoint is 6% above the US median for Clinical Quality & Safety roles at this level.
This roleEmployer provided
Director roles in California5 roles publishing pay
Director roles in the US19 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $222,480 | — | $259,560 |
| California (middle half) | $227,500 | $241,000 | $244,500 |
| All US (middle half) | $205,500 | $228,000 | $253,500 |
This role: Cytokinetics's own published range. Comparisons: the base pay employers published on open Clinical Quality & Safety roles at the same level on Regulatory Jobs, October 15, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Quality & Safety
The general path across 34 open Clinical Quality & Safety roles on Regulatory Jobs, with the titles they carry most. Not Cytokinetics's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 21 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- GMP and compliance13
- Collaboration and leadership10
- Documentation and SOPs3
- Quality systems and risk2
- Investigations and CAPA1
Regulatory intelligence
The rules behind this role
Frameworks and standards this posting's work falls under, matched from its own words, each linked to the official source.
Company hiring pulse
Cytokinetics on Regulatory Jobs
- 12
- Open roles
- 11
- Distinct roles
- 2
- Locations
By discipline
- Regulatory6 50%
- Quality4 33%
- Compliance & Safety2 17%
By level
- Director5 42%
- Manager5 42%
- Senior & Principal2 17%
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Director, Clinical Quality Assurance at Cytokinetics
Open until filled. $222K–$260K a year, employer provided.