Manager, Quality Systems - Document Control (Contract)
Cytokinetics
Summary
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.
Job description
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.
Responsibilities
- 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.
Skills & Qualifications
- 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.
Requirements
- 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
Company overview
Cytokinetics, Incorporated is a late-stage biopharmaceutical company headquartered in South San Francisco, California, specializing in muscle biology research and drug development. Founded in 1997 by leading scientists from Stanford, UCSD, and UCSF, the company focuses on discovering, developing, and commercializing first-in-class muscle activators and next-in-class muscle inhibitors for debilitating diseases characterized by impaired or declining muscle function. With over 25 years of scientific expertise, Cytokinetics has built a robust pipeline targeting cardiovascular and neuromuscular conditions including heart failure, hypertrophic cardiomyopathy, and amyotrophic lateral sclerosis (ALS). The company's innovative approach centers on directly targeting the sarcomere, the fundamental unit of muscle contraction, to develop potential treatments that may preserve and extend independence for patients. Cytokinetics operates as a publicly traded company (NASDAQ: CYTK) and has established itself as a leader in muscle biology with more than 115 publications, over 100 clinical trials, and hundreds of issued patents.