Senior Director Good Manufacturing Practices Computer System Validation Quality Assurance
Senior Director Good Manufacturing Practices Computer System Validation Quality Assurance
Posted on :
21-04-2025
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1 Vacancy
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Monthly Salary
$ 225250 - 278250
Vacancy
1 Vacancy
Posted on :
21-04-2025
Job Description
IDEAYA Biosciences (NASDAQ: IDYA) is a public clinicalstage precision medicine oncology company committed to the discovery development and commercialization of targeted therapeutics for patient populations with high unmet clinical needs. Our approach integrates extensive capabilities in identifying and validating translational biomarkers with small molecule drug discovery to select patient populations most likely to benefit from the therapies we are developing. We have developed an industry leading platform and pipeline in precision medicine by applying these capabilities across multiple approaches such as direct targeting of oncogenic pathways and synthetic lethality which represents an emerging class of precision medicine targets. We believe this diversified approach will enable us to deliver the right medicine to the right patient to drive a more robust clinical response. IDEAYA has established strategic collaborations with GSK Merck Pfizer and Gilead but whollyowns or controls its four mostadvanced clinical programs and we are committed to building a bestinindustry organization to deliver our precision medicines to the people who need them.
When youre at IDEAYA you will be in the midst of brilliant minds working on precision medicine therapies to help cancer patients. We are passionate and committed about being on the forefront of oncology medicine which means we all have a high internal drive that is at the very core of every person at IDEAYA. We are inquisitive ask deep questions and are datadriven innovators who like to collaborate and use teamwork to move science forward. For more information please see .
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
Position Summary:
The Sr Director GMP & CSV QA is a senior 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 Sr. Director will lead a team of QA professionals 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 QA.
This position is based in our South San Francisco headquarter offices and required to be onsite four days per week per our company policy.
What youll 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 followup actions to ensure effective resolution of nonconformance 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 GMPrelated 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 crossfunctional 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 highperforming 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.
Preferred Qualifications
- Advanced degree in life sciences pharmacy chemistry or a related field (PhD MS or equivalent preferred).
- Minimum of 15 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 inhouse manufacturing.
- Proven track record and relevant industry experience in leading GMP QA functions within a global organization. Flexibility to work in a fastpaced 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 teambuilding skills strong analytical problemsolving and decisionmaking 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.
$225250 $278250 a year
At IDEAYA Biosciences we care about our employees and strive to provide a marketcompetitive total rewards package including base pay an annual performance bonus company equity and generous health and wellbeing benefits. The expected salary range for this role that is based in our South San Francisco California office is $225250 $278250.
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.
The Company complies with all laws respecting equal employment opportunities and does not discriminate against applicants with regard to any protected characteristic as defined by federal state and local law. This position requires you to work onsite at the Companys facilities with partial workfromhome flexibility and the Company requires that all employees working in its facilities be fully vaccinated (except as required by applicable law). Therefore this position requires you to be fully vaccinated from COVID19 subject to reasonable accommodations for medical or religious reasons and/or as otherwise required by applicable law. The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a twodose COVID19 vaccine series or a singledose COVID19 vaccine. The vaccine must have been FDA approved have emergency use authorization from the FDA or for persons fully vaccinated outside of the U.S. be listed for emergency use by the World Health Organization.
Total Rewards:
Along with our inspiring mission and highly collaborative and inclusive environment IDEAYA offers a competitive total rewards package that reflects our payforperformance philosophy where employees are eligible to be considered for meritbased salary increases company discretionary shortterm incentive plan participation and company discretionary stock option awards (based on board approval). Our comprehensive benefits package includes but is not limited to medical/dental/vision coverage 100 company paid for employees and 90 company paid for dependents) 401k ESPP and wellness programs.
IDEAYA is an equal opportunity employer. In accordance with applicable law IDEAYA does not discriminate in hiring or otherwise in employment based on race color religion sex national origin age marital or veteran status disability sexual orientation or any other legally protected status. EOE/AA/Vets.
Required Experience:
Exec
Employment Type
Full-Time
Key Skills
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