Senior Quality Assurance Specialist - Drug Substance

Regulatory Jobs; South San Francisco (CA); On-site; USD 140,000 - 164,000; Full time

Benefits offered by this job

Stock options

Health, dental, vision, life insurance

401k with employer match

Wellness stipends

Paid time off

Job summary

Cytokinetics, a specialty cardiovascular biopharmaceutical company, is seeking a QA Specialist for Drug Substance. You will perform review of batch documentation for QA certification and oversee documentation for manufacturing, testing, release, and lifecycle management with CMOs and CTLs.

You will support the QP function, advise internal/external customers, and provide QA support to cross-functional teams across clinical and commercial programs.

Qualifications

• Bachelor's degree in a scientific, engineering or technical discipline.
• Minimum of 5 years in biopharmaceutical or pharmaceutical QA with at least 3 years in GMP QA.
• Experience supporting clinical and/or commercial pharmaceutical manufacturing.
• Experience with oral solid dose manufacturing and packaging.
• Working knowledge of US FDA, EU EMA and ICH cGMP regulations.
• Experience reviewing GMP batch documentation and batch disposition.
• Experience managing deviations, investigations, CAPAs, change controls and QA records.
• Experience supporting CMOs and external manufacturing operations.
• Experience participating in GMP audits and regulatory inspections.
• Excellent written/verbal communication; strong organization.

Responsibilities

• Provide GMP QA oversight for clinical and commercial manufacturing and distribution at CMOs.
• Review batch records and supporting docs to ensure cGMP compliance.
• Review and approve deviations, investigations, CAPAs, change controls and QMS records.
• Assess quality events for product impact and support risk-based decisions.
• Support tech transfers, process validation, PPQ and commercial launches.
• Review GMP documentation including SOPs, MBRs, specs and protocols.
• Participate as QA representative on cross-functional teams.
• Support manufacturing/process improvements through change management.
• Ensure compliance with QMS and global regulatory expectations.
• Support qualification/oversight of CMOs and contract labs.
• Participate in audits/regulatory inspections and responses.
• Support Product Quality Reviews and annual product reviews, QA metrics.
• Collaborate with Regulatory, Ops, Supply Chain and Manufacturing on CMC submissions.
• Maintain GMP documentation in eQMS.
• Identify opportunities to improve GMP processes and drive continuous improvement.
• Provide guidance on GMP quality across stakeholders.

Skills

GMP Quality Assurance

Documentation review

Batch records review

Deviations & CAPAs

Regulatory inspections

eQMS (Veeva/TrackWise)

Cross-functional collaboration

Quality risk assessment

Education

Bachelor's degree in science/engineering

Tools

Veeva Quality

TrackWise

Job description

Cytokineticsis 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.

Reporting to the Associate Director for QA at Cytokinetics the QA Specialist for Drug Substance will perform review of batch documentation as part of the QA certification process. The role involves oversight and review of documentation relating to manufacturing, testing, release, and lifecycle management activities performed by Contract Manufacturing Organizations (CMOs), Contract Testing Laboratories (CTLs), and other GxP service providers.

The candidate will be part of a team that provides QA support and advice to internal and external customers and will execute day-to-day quality issues as they arise at Cytokinetics. They will be part of teams who work with Contract Manufactures for Drug product (DP). The role will provide support to the Qualified Person (QP) function to oversee our QA activities as we continue to supply our products.

Responsibilities

• Provide GMP Quality Assurance oversight for clinical and commercial manufacturing, and distribution activities performed at Contract Manufacturing Organizations (CMOs).
• Perform Quality review of clinical and commercial batch records and supporting documentation to ensure compliance with cGMP requirements, approved manufacturing instructions and regulatory filings.
• Review manufacturing, and testing documentation to support batch disposition and product release.
• Review and approve deviations, investigations, CAPAs, change controls and associated Quality Management System records to ensure timely resolution and appropriate root cause analysis.
• Assess quality events for potential product impact and support risk-based quality decisions.
• Provide Quality support for technology transfers, process validation, engineering batches, process performance qualification (PPQ) and commercial launch activities.
• Review and approve GMP documentation including Standard Operating Procedures (SOPs), Master Batch Records, specifications, protocols, reports and work instructions.
• Participate as the Quality representative on cross-functional teams supporting clinical and commercial programs.
• Support implementation of manufacturing, packaging and process improvements through the change management process.
• Ensure compliance with Cytokinetics Quality Management System requirements, cGMP regulations and applicable global regulatory expectations.
• Support qualification and ongoing Quality oversight of CMOs, contract laboratories and other GMP service providers.
• Participate in internal audits, supplier audits and regulatory inspections, including inspection readiness activities and support for responses to audit observations.
• Support Product Quality Reviews (PQRs), Annual Product Reviews (APRs), Quality Management Reviews and Quality Metrics reporting.
• Collaborate with Regulatory Affairs, Technical Operations, Supply Chain and Manufacturing partners to support CMC submissions, post-approval changes and regulatory commitments.
• Maintain GMP documentation and Quality records within the electronic Quality Management System (eQMS).
• Identify opportunities to improve Quality Systems and GMP processes and participate in continuous improvement initiatives.
• Provide guidance to internal stakeholders and external partners on GMP quality requirements.
• Perform other Quality Assurance duties as assigned to support business objectives.

Minimum Qualifications

• Bachelor's degree in a scientific, engineering or technical discipline.
• Minimum of 5 years of experience within the biopharmaceutical or pharmaceutical industry, with at least 3 years in GMP Quality Assurance.
• Experience supporting clinical and/or commercial pharmaceutical manufacturing.
• Experience with oral solid dose pharmaceutical manufacturing and packaging.
• Working knowledge of US FDA, EU EMA and ICH cGMP regulations and industry guidance.
• Experience reviewing GMP batch documentation and supporting batch disposition activities.
• Experience managing or reviewing deviations, investigations, CAPAs, change controls and other Quality System records.
• Experience supporting Contract Manufacturing Organizations (CMOs) and external manufacturing operations.
• Experience participating in GMP audits and regulatory inspections.
• Excellent written and verbal communication skills with the ability to work effectively across multiple functions and external partners.
• Strong organizational skills with the ability to manage multiple priorities while maintaining attention to detail.
• Experience authoring and reviewing SOPs and controlled GMP documentation.
• Experience using electronic Quality Management Systems (eQMS), preferably Veeva Quality, TrackWise or similar platforms.

Preferred Qualifications

• Experience supporting commercial product launches.
• Experience supporting technology transfer and process validation activities.
• Knowledge of ICH Q7, Q8, Q9 and Q10 guidance.
• Experience working within a global external manufacturing network.
• Continuous improvement or Lean Six Sigma experience is desirable.

Pay Range

The expected salary range for this position based on the primary location of South San Francisco, CA is $140,400-$163,800. The base pay offered will take into account internal equity and may vary depending on the candidate's geographic region, job-related knowledge, skills, and experience among other factors. Base salary is just one component of our competitive total compensation package, which includes equity in the form of stock options and/or restricted stock units, comprehensive health, dental, vision, life and disability insurance coverage, 401k retirement benefits with employer match, learning and wellness stipends, and paid time off.

• equity in the form of stock options and/or restricted stock units
• comprehensive health, dental, vision, life and disability insurance coverage
• 401k retirement benefits with employer match
• learning and wellness stipends
• paid time off

Note that benefits are subject to change and may vary based on jurisdiction of employment.

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.

Cytokinetics is an Equal Opportunity Employer