Director, Good Manufacturing Practices & Computer System Validation Quality Assurance Join to apply for the Director, Good Manufacturing Practices & Computer System Validation Quality Assurance role at BioSpace Director, Good Manufacturing Practices & Computer System Validation Quality Assurance 1 week ago Be among the first 25 applicants Join to apply for the Director, Good Manufacturing Practices & Computer System Validation Quality Assurance role at BioSpace Get AI-powered advice on this job and more exclusive features. Job Summary

Find out more about this role by reading the information below, then apply to be considered.

ABOUT IDEAYA:

IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.

Notice to Agencies and Recruiters: All open positions and candidate activity are strictly managed through Human Resources. Please note that our policy is that recruiters do not contact employees/hiring managers directly to solicit business and/or present candidates. Submission of unsolicited resumes prior to an agreement set in place between the Human Resources Department and the recruiting agency will not create any implied obligation. Please note that failure to comply with this request will be a factor in developing a professional relationship with IDEAYA Bio. Inquiries regarding developing a recruiting relationship with us, may be directed to HR@ideayabio.com.

Position Summary

The Director, GMP & CSV QA is a leadership role responsible for developing and maintaining Good Manufacturing Practices (GMP) and Computer System Validation (CSV) Quality Systems as well as supporting internal and external compliance activities. Direct responsibility, authority, and accountability for the Deviation, Corrective Action/Preventive Action (CAPA), Change Control, and Batch Release Systems. Responsibilities will also include acting as QA liaison to various project teams. The candidate will ensure compliance with regulatory requirements, industry standards, and company policies for the manufacturing, testing, release, and distribution of pharmaceutical products (clinical and commercial). The Director will provide strategic leadership, drive continuous improvement initiatives, provide quality oversight of contract organizations, and ensure the highest standards of product quality and patient safety. This position will report to the Vice President, Quality.

This position is based in our South San Francisco headquarter offices or San Diego office and required to be onsite four days per week per our company policy.

Job Description

What you’ll do:

Develop and implement the global GMP & CSV QA strategy aligned with corporate goals, Ideaya SOPs and global regulatory requirements. Ensure compliance with global GMP regulations (e.g., FDA, EMA, PMDA, ICH Q7, Q10) and company standards. Develop procedures and work flows to define key Quality Systems including Deviation, CAPA, Change Control and Document management. Ensure that cGMP departments and Operating units within Ideaya have written procedures to support GxP activities. Oversee the development, implementation, and maintenance of GMP QA policies, quality agreements, standard operating procedures, and quality systems processes and workflows to manage quality events. Manage and oversee all aspects of GxP quality functions for clinical and commercial products i.e., Lot Release, Quality Systems records (i.e., Deviations, Change Control, Complaints, Audits, Product Quality Review). Monitor emerging regulatory trends and ensure proactive adaptation of QA processes. Compile, track quality metrics (KPI) on process, product attribute and supplier performance and report to management on a quarterly basis. Lead and manage GMP audits programs (internal and external), including manufacturing sites, contract manufacturers and packagers, suppliers, and laboratories. Host and support regulatory inspections, ensuring inspection readiness and timely resolution of findings. Represent GMP QA in regulatory inspections, partner audits, and due diligence activities. Review and approve audit reports, CAPA plans, and follow-up actions to ensure effective resolution of non-conformance and quality events. Lead or oversee the annual product quality review (APQR) process to ensure ongoing evaluation of product quality and compliance. Drive continuous improvement initiatives based on key performance indicators (KPIs), APQR findings and trends. Identify, assess, and mitigate GMP-related risks across the supply chain (end to end), GMP vendors and manufacturing processes. Provide expert guidance on GMP & CSV compliance and escalate critical quality events, nonconformances and compliance issues to cross-functional teams and senior management. Collaborate with manufacturing, supply chain, regulatory affairs, and other stakeholders to address quality issues and drive continuous improvement. Build, mentor, and lead a high-performing GMP & CSV QA team. Foster a culture of quality, accountability, and collaboration within the team and across the organization. Partner with CMC, regulatory affairs, IT and R&D to ensure alignment on quality and compliance objectives. Support the development and review of batch records, specifications, test methods, protocols, and other critical documents. Oversee the selection, qualification, and ongoing monitoring of all GMP vendors, including contract manufacturers, suppliers, and testing laboratories. Ensure vendor compliance with contractual obligations, quality agreements and regulatory requirements.

Requirements

Advanced degree in life sciences, pharmacy, chemistry, or a related field (PhD, MS, or equivalent preferred). Minimum of 12 years of experience in the pharmaceutical or biotechnology industry, with at least 8 years in GMP QA or manufacturing quality roles working in a firm with in-house manufacturing. Proven track record and relevant industry experience in leading GMP QA functions within a global organization. Flexibility to work in a fast-paced, dynamic environment with evolving priorities. Strong knowledge of global GMP & CSV regulations, ICH guidelines, and pharmaceutical manufacturing processes. Experience hosting regulatory inspections (e.g., FDA, EMA, PMDA) and managing Ideaya audit programs. Exceptional leadership and team-building skills, strong analytical, problem-solving, and decision-making abilities. Excellent communication and interpersonal skills, with the ability to influence stakeholders at all levels. Strategic thinker with a focus on continuous improvement and innovation. This role may require occasional travel (up to 20%) for audits, inspections, and meetings.

Preferred Skills

Prior supervisory or function management experience is required.

Salary Range: $187,000 - $231,000

At IDEAYA Biosciences, we care about our employees and strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health and well-being benefits. The expected salary range for this role that is based in our South San Francisco or San Diego, California office is $187,000 - $231,000.

The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the office location where this open position is located, the final candidates’ experience within their profession, experience in the disease areas we are striving to make an impact in as a company, length of time within the industry, educational background, and performance during the interview process.Seniority level Seniority levelDirector Employment type Employment typeFull-time Job function Job functionManagement and Manufacturing IndustriesInternet News Referrals increase your chances of interviewing at BioSpace by 2x Sign in to set job alerts for “Director of Manufacturing” roles.Vice President, Manufacturing Operations Brisbane, CA $319,000.00-$355,000.00 1 week ago Hayward, CA $271,000.00-$326,000.00 2 weeks ago Fremont, CA $309,000.00-$358,000.00 3 days ago Director, Drug Product Development & Manufacturing San Mateo, CA $191,200.00-$274,850.00 16 hours ago San Mateo, CA $191,200.00-$274,850.00 16 hours ago San Francisco, CA $160,000.00-$175,000.00 3 weeks ago South San Francisco, CA $205,000.00-$229,000.00 3 weeks ago Associate Director Device Development & ManufacturingExecutive Director of MFG Sciences and Technology South San Francisco, CA $260,000.00-$310,000.00 2 weeks ago Foster City, CA $180,000.00-$200,000.00 2 weeks ago San Mateo, CA $217,000.00-$301,000.00 4 days ago Redwood City, CA $186,500.00-$219,400.00 1 week ago Fremont, CA $112,500.00-$150,000.00 1 day ago Engineering Director ( Electronics Manufacturing ) San Francisco, CA $210,000.00-$260,000.00 2 weeks ago San Francisco, CA $144,066.00-$190,000.00 2 weeks ago Director of Enterprise Programs, Process DevelopmentDirector of Operations | Residential Real Estate Sausalito, CA $70,000.00-$75,000.00 1 day ago Fremont, CA $172,500.00-$230,000.00 4 hours ago Director, Digital Innovation and Operations San Francisco, CA $152,500.00-$202,000.00 2 months ago South San Francisco, CA $220,000.00-$245,000.00 2 months ago Fremont, CA $130,000.00-$165,000.00 1 week ago Director of Operations (must have Port/Terminal experience) Oakland, CA $175,000.00-$215,000.00 2 days ago Director of Studio Operations and FacilitiesManager Optical Planning - Manufacturing San Francisco, CA $206,000.00-$326,000.00 2 weeks ago San Francisco, CA $100,000.00-$140,000.00 3 months ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr