About this 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.
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.
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Pay Range:
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 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]
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer