New · posted Nov 11
Cytokinetics · Pharmaceuticals
Manager, Quality Systems - Document Control
- South San Francisco, CA
- Hybrid
- Contract
- Manager
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 Quality Systems Manager is responsible for managing day-to-day GxP document control processes, ensuring controlled documents and quality records are compliant with regulatory requirements, internal standards, and company procedures.
This role reports to the Senior Manager of Quality Systems and acts as a subject matter expert and collaborates with cross-functional teams to support the document lifecycle, drive process improvements, maintain inspection readiness, and promote compliance with quality system requirements.
What you need
- Bachelor's degree in Life Sciences, Quality, Business, or a related discipline, or equivalent combination of education and experience.
- 6+ years of experience in Document Control and Quality Systems within a regulated GxP environment.
- Demonstrated experience managing document control processes and electronic document management systems.
- 2+ years of recent experience administering Veeva Vault QualityDocs and Vault Training.
- Strong knowledge of FDA, EMA, ICH, and applicable GxP regulations governing quality documentation.
- Experience supporting regulatory inspections, customer audits, and internal audits.
- Advanced proficiency in Microsoft Office Suite, particularly Microsoft Word for document formatting and template management.
- Excellent organizational skills with strong attention to detail and the ability to manage multiple priorities in a fast-paced environment.
- Strong written, verbal, and interpersonal communication skills with a collaborative, customer-focused approach.
- Experience with quality metrics, process improvement, and inspection readiness preferred.
What you'll do
- Manage day-to-day document control operations and ensure controlled documents are maintained throughout their lifecycle in the electronic document management system (e.g., SOPs, Policies, Work Instructions, Forms) in compliance with Business Process and GxP requirements.
- Serve as a subject matter expert for the electronic document management system, including document workflows, user support, testing, and implementation of system enhancements as applicable.
- Partner with document authors, reviewers, approvers, and cross-functional stakeholders to facilitate timely document review, approval, issuance, periodic review, and retirement activities.
- Support the development, maintenance, and continuous improvement of document control procedures, standards, templates, and best practices to support an effective Quality Management System.
- Provide guidance and training to document authors, collaborators, reviewers, and approvers on GxP documentation practices, document management processes, and electronic document management system functionality.
- Demonstrated ability to develop, deliver, and facilitate end-user training for Electronic Document Management Systems (EDMS), including creating training materials and user guides.
- Monitor and report document control metrics, identify trends, and recommend process improvements to enhance efficiency, compliance, and document quality.
- Support change controls, CAPAs, deviations, and continuous improvement initiatives related to document control processes.
- Support internal audits, external audits, and regulatory inspections by providing documentation, records, and subject matter expertise related to document control systems.
- Ensure document control processes remain inspection-ready and compliant with applicable FDA, EMA, ICH, and other GxP regulatory requirements.
- Provide Training coverage as needed.
Pay
Cytokinetics didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
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.
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 · November 11, 2026
Salary intelligence
How the pay compares
Manager roles in California9 roles publishing pay
Manager roles in the US20 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| California (middle half) | $159,000 | $165,500 | $181,000 |
| All US (middle half) | $142,000 | $154,500 | $166,750 |
Comparisons: the base pay employers published on open Quality Systems & Document Control roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Quality Systems & Document Control
The general path across 96 open Quality Systems & Document Control 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 24 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Documentation and SOPs16
- GMP and compliance11
- Quality systems and risk7
- Collaboration and leadership7
- Lab testing and methods2
- Data and digital systems2
- Investigations and CAPA1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Quality Systems & Document Control work in pharmaceuticals, each linked to the agency or standards body that publishes it.
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- FDAFDA quality agreements guidance(official source, opens in a new tab)Contract Manufacturing Arrangements for Drugs: Quality Agreements
- FDA21 CFR Part 7(official source, opens in a new tab)FDA enforcement policy, including product recalls
- PIC/SPIC/S(official source, opens in a new tab)The Pharmaceutical Inspection Co-operation Scheme and its GMP guide
- ICHICH Q7(official source, opens in a new tab)Good manufacturing practice for active pharmaceutical ingredients
- ISOISO 9001(official source, opens in a new tab)Quality management systems requirements
- WHOWHO good manufacturing practices(official source, opens in a new tab)World Health Organization GMP norms and standards for medicines
Company hiring pulse
Cytokinetics on Regulatory Jobs
- 17
- Open roles
- 17
- Distinct roles
- 2
- Locations
By discipline
- Regulatory7 41%
- Quality6 35%
- Clinical4 24%
By level
- Manager8 47%
- Director7 41%
- Senior & Principal2 12%
More roles at Cytokinetics
- View role
Director, Quality Systems
South San Francisco, CA · HybridDirectorPharmaceuticals$225K–$263K
- View role
Manager, Quality Systems - GxP Training
South San Francisco, CA · HybridManagerPharmaceuticalsSalary not listed
- View role
Senior Director, Medical Safety & Pharmacovigilance
South San Francisco, CA · HybridDirectorBiotechnology$351K–$410K
- View role
Senior Manager, CMC Quality Control
South San Francisco, CAManagerPharmaceuticals$182K–$212K
Similar Quality Systems & Document Control roles elsewhere
- View role
Senior Manager, Quality Systems
AbbVieIrvine, CAManagerPharmaceuticals$125K–$237K
- View role
Senior Manager, External Quality Business Processes and Strategic Projects
Johnson & JohnsonHorsham, PAManagerPharmaceuticalsSalary not listed
- View role
Device Quality Senior Manager
AbbVieNorth Chicago, ILManagerPharmaceuticals$125K–$237K
- View role
Sr Quality Manager, QMS
Becton DickinsonEl Paso, TXManagerPharmaceuticalsSalary not listed
Manager, Quality Systems - Document Control at Cytokinetics
Open until filled.