Associate Director, Quality Assurance - CMC OperationsPosition SummaryThis Associate Director, Quality Assurance role will be responsible for leading and managing QA activities, oversight, and support to Protagonist's CMC team with GMP manufacturing. This individual will provide QA leadership, expertise, and guidance regarding regulatory requirements, and GMP guidelines to ensure GMP Manufacturing compliance.
This position will report to the Executive Director QA and be an integral part of the QA team. In this role, the individual will utilize a risk-based strategy to prioritize QA GMP support activities (review of executed batch records, deviations, analytical data, stability data, and other GMP documents and reports), identify, and escalate compliance issues to enable pro-active decision-making supporting GMP activities.
We are committed to a thriving in-office culture. This role requires being on-site at our office in Newark, CA 4 days a week.Responsibilities- Serve as Quality Lead for assigned CMC program(s) supporting GMP API manufacturing.
- Provide QA oversight of GMP manufacturing and analytical operations.
- Review and approve Master Batch Records (MBRs) and change controls to ensure accuracy, completeness, and compliance with cGMP requirements, including appropriate impact assessments, risk evaluation, and product quality expectations.
- Review and approve product specifications to ensure they are scientifically justified, aligned with regulatory expectations, and appropriate for ensuring product quality, safety, and consistency.
- Provide Quality Assurance oversight of external analytical laboratories, ensuring method lifecycle activities (qualification, verification and validation) are executed in compliance with cGMP and ICH with appropriate review and approval of protocols, reports and methods
- Review and approve laboratory investigations (OOS/OOT/deviations) conducted by external laboratories ensuring thorough root cause analysis, robust corrective and preventative actions (CAPA), and aligned decision-making impacting product quality and disposition.
- Partner with cross-functional teams to identify, assess, and mitigate quality risks impacting product quality, patient safety, and supply continuity.
- Ensure quality risk decisions are appropriately justified, documented and aligned with internal procedures and regulatory expectations.
- Partner with CMC to resolve quality issues arising during manufacturing, laboratory activities and material receipt and shipping.
- Review and approve manufacturing records, deviations, investigations, change controls, and CAPA to ensure product quality and support timely product dispositions.
- Review executed batch records and supporting documentation for lot disposition, ensuring completeness, accuracy, and compliance with cGMP requirements, and confirming that all deviations, investigations, and quality events are appropriately resolved prior to batch release.
- Support regulatory inspections and internal audits.
- Respond to and help resolve issues related to inspection findings.
- Manage QA Vendor Audit Plan and perform some Vendor Qualifications / Audits.
- Perform QA GMP vendor audits and write audit reports with findings, when necessary.
- Provide CMC team with GMP Audit results regarding the conduct of vendor and make appropriate recommendations.
- Monitor progress of GMP Vendors to successfully respond with mitigation activities to close out Findings and Audit.
- Review and approve stability protocols and reports to ensure study design, data integrity, and conclusions are scientifically sound, compliant with cGMP and regulatory expectations, and supportive of product shelf life and storage conditions.
- Manage, review, and approve change controls (CC) and CC packages for closure.
- Investigate, manage, and approve product complaints reports for closure,
- Assist with product recall / stock recovery investigations and reports, as necessary,
- Keep current on changes in applicable FDA and European regulations, directives, and guidelines and advise on potential impact to GMP activities.
- Must be capable and willing to travel (up to 25%), including international travel.
- Maintain flexibility to perform other additional tasks as assigned.
Required Skills & Qualifications- Bachelor's Degree in a scientific or related discipline with advanced degree preferred.
- Typically requires a minimum of 10+ years in biotech/pharmaceutical industry, with Quality Assurance experience.
- Experience with preparing for regulatory inspections, assessing inspection readiness, and hosting regulatory inspections & other audits.
- Demonstrated expertise and ability to interpret and apply EU, FDA and ICH regulations and guidance documents.
- Self-motivated and comfortable with minimal direction.
- Proficient in organization, prioritization, time management, and able to manage multiple priorities.
- Proficient computer skills and experience with commonly used productivity software.
- Excellent oral and written communication skills.
- Demonstrated ability to work effectively in cross-functional teams.
- Strong focus on quality and attention to detail.
Pay Range The base pay range for this position at commencement of employment is expected to be between $175,000 and $225,000/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.
BenefitsA top priority for Protagonist Therapeutics, Inc. is to provide a robust and comprehensive health and wellness program for our employees and their families. We offer a variety of high-quality coverage and benefit options.
- Health Care benefits. Protagonist covers 100% of the premium cost for medical, dental, and vision coverage for all full-time employees and their dependents.
- Flexible Spending Accounts - Healthcare FSA, Dependent Care FSA, Commuter Benefits
- 401(k) Plan
- Flexible Vacation Policy
- Life Insurance (Basic, Voluntary & AD&D)
- Short Term & Long Term Disability
- Company paid lunch and snacks
