Associate Director, Quality Assurance

CytokineticsSan Francisco, CA, US

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Cytokinetics is a late-stage, specialty cardiovascular 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 cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.

Cytokinetics is seeking a highly motivated individual to join our team as Associate Director of Quality Assurance with responsibility for oversight of Quality Control activities. You will have the opportunity to create and ensure quality processes and systems are optimized and carried out appropriately to support GMP development and commercial activities for our first product launch!

The Associate Director, QA will be responsible for oversight of Quality Control (QC) test data in a pharmaceutical manufacturing environment, with a principal focus on data associated with stability studies and lot release. This is NOT a QC role, but a QA leadership position dedicated to ensuring the accuracy, integrity, and compliance of all QC data, processes, and records. The role functions as a key partner with Global Supply Chain and Technical Operations Analytical groups, Regulatory Affairs, and other departments to ensure all testing and data management meet regulatory and company standards.

Responsibilities

Provide QA oversight of QC-generated data, particularly for product stability and lot release, ensuring compliance with cGMP, FDA, EMA, and other relevant regulations.
Collaborate closely with Technical Operations Analytical groups to ensure QC data that support stability and lot release are compliant with specifications and xxx
Oversee all aspects of QC data including review and approval of clinical and commercial stability products, which encompasses all starting materials, drug substance intermediates, drug substance, critical components, drug product intermediates, and drug products for a clinical and commercial program
Review and approve :
Stability protocols
OOS / OOT investigations
Trend reports and final summary reports
Oversee timely data evaluation and escalations related to product shelf-life or specification trends.
Support oversight of QC activities at CMOs including review of release and stability raw data, data quality, and adherence to timelines.
Review and approve SOPs and quality documentation related to Quality Assurance, QC and stability.
Oversee the generation, review, and approval of CoAs for Drug Substance, final product release and stability batches.
Ensure CoAs :
Accurately reflect analytical results
Comply with product specifications and regulatory filings
Are reviewed for completeness, traceability, and data integrity
Serves as QA representative in cross-functional working teams and / or working with outside vendors to meet stability needs.
Support batch release decisions through QA review of CoAs and associated QC data
Collaborate with Technical Operations to ensure stability studies are initiated within project timelines and proactively monitor studies to ensure compliance with study protocols, quality agreements and regulatory commitments
Oversee the stability program and QC testing in accordance with Cytokinetics procedures and regulatory guidelines.
Assist Technical Operations in the reviews of both internal and external (CMO) records, including stability test records / reports, protocols, change controls, deviations, and OOS.
Assist in the preparation of CMC regulatory submissions.
Authors, reviews, and / or approve data and trending reports
Identifies areas for improvement and drives projects to implement solutions.
Effectively communicate with internal and external stakeholders
Monitor, track and publish stability program metrics
Ensure all records adhere to cGMP / GDP expectations
Participate in project team meetings, Materials Review Board Meetings, and other meetings as applicable
Maintain a thorough knowledge of appropriate standard operating procedures, and recommend / initiate SOP updates and improvements as appropriate
Participate in conducting internal and vendor audits
Support regulatory agency inspections as required
Perform other related duties as assigned from time to time based on company needs such as maintaining and managing all QA Ops GMP documents, controlled documents and quality records according to company policies and procedures.

Minimum Qualifications

Bachelor's Degree in a scientific or technical discipline with 7+ years' experience in the biopharmaceutical or pharmaceutical industry with at least 5 years of experience within QA / QC

Ability to work in a collaborative team environment is essential

Experience with clinical / commercial QC / stability programs.

Knowledge of US and EU cGMP regulations / guidance.

Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail

Effective communication skills, both verbal and written.

Must have strong analytical and interpersonal communication skills

Experience writing, reviewing and editing SOPs and specifications

Experience using electronic Quality Management Systems is a plus

Knowledge of pharmaceutical regulations within the US (FDA) and Europe (EMA) required; additional knowledge of other ROW regulations a plus.

Pay Range

In the U.S., the hiring pay range for fully qualified candidates is $195,300 -$227,850 per year. The base pay actually offered will take into account internal equity and also may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors.

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 talentacquisition@cytokinetics.com

Please visit our website at : www.cytokinetics.com

Cytokinetics is an Equal Opportunity Employer

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Quality Assurance

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Associate Quality Assurance • San Francisco, CA, US