Senior Manager, QA Operations

Cytokinetics is a late-stage biopharmaceutical company focused on discovering, developing, and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact muscle function and contractility.

We view our employees as the unequivocal ingredients to success. Each and every employee is an integral member of the Cytokinetics team, contributing to our shared goal of improving lives. While expectations of our employees are high, there is an equal commitment to ensuring that contributions are recognized and rewarded. We seek exceptional individuals to join us in our mission to develop potential medicines to improve the health-span of people with cardiovascular and neuromuscular diseases of impaired muscle function.

Cytokinetics is seeking a highly motivated individual to join our team as Senior Quality Operations Manager. You will have the opportunity to create and assure quality processes and systems are optimized and carried out appropriately to support GMP development and commercial activities for our first product launch! You will provide oversight, guidance and support for product release activities, to ensure compliance with company’s procedures, company policies, and regulatory guidelines.

Responsibilities

• Partner with Global Supply Chain and Technical Operations in the development/optimization of documentation necessary to produce clinical trial materials across all phases of development and commercialization while ensuring compliance to specifications and SOPs
• Review and approve various types of batch history records (analytical method validation, product specifications, drug product manufacture, filling, packaging, labeling, etc.) including guidance and support on deviations
• Oversee the contract manufacturing organizations and represent QA as the person-in-the-plant (PIP) during manufacturing campaigns, as needed
• Partner with Technical Operations and contract service providers to assess and resolve deviations, product complaints, OOS test results, and other quality issues, which may arise, in a timely manner; participate in investigations and scrutinize proposed CAPAs for feasibility and compliance
• Provide Change Control guidance/oversight by working with internal groups and contract sites, assisting with change proposal approval and drafting of implementation Provide resources for implementation plan execution when necessary
• Serve as a resource for personnel seeking information on FDA/ROW regulations, guidelines and quality practices associated with the pharmaceutical industry
• Track metrics, analyze compliance issues and trends to improve quality systems and overall compliance
• Participate in project team meetings, Materials Review Board Meetings, and other meetings as applicable
• Initiate SOP updates and improvements, as appropriate, by maintaining a thorough knowledge of appropriate standard operating procedures
• Participate in the development and presentation of training on SOPs, regulations, and quality concepts
• Participate in conducting internal audits to support submission readiness and vendor audits to ensure compliance with regulations and regulatory agency inspections

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.

Qualifications

• Bachelor’s Degree in a scientific or technical discipline with 7+ years’ experience in the biopharmaceutical or pharmaceutical industry or QA operations experience
• A solid understanding of the differences in requirements for clinical trial material/ drug manufacturing at various phases of clinical development and commercialization
• Experience conducting investigations of deviations, product complaints and other quality issues through critical thinking in the assessment of risk to patients, study integrity, data integrity and scientific validity
• Knowledge of pharmaceutical regulations within the US (FDA) and Europe (EMA) required; additional knowledge of other ROW regulations a plus
• Solid analytical and interpersonal communication skills
• Experience writing, reviewing and editing SOPs and specifications
• Experience using electronic Quality Management Systems is a plus
• Person-in-plant experience a plus