Associate Director, GMP Quality Assurance - Qualified Person

About the Role >>> Associate Director, GMP Quality – Qualified Person

As the Qualified Person (QP), reporting to the Senior Director, Quality Assurance based in San Francisco, California, USA you will hold responsibility for ensuring that Clinical and Commercial medicinal products are manufactured, tested and released in compliance with applicable regulatory requirements of the European Union. You will also ensure that the products are prepared for certification by QPs of the United Kingdom and Israel and are compatible with U.S requirements.

You will be responsible for conducting Supplier and Contract Service Provider audits within the European Economic Community and other geographies. You will monitor changes to European regulatory requirements and host any inspections conducted by the Health Product Regulatory Authority (HPRA) or other Competent Authorities of the European Union. You will be an integral participant in annual Quality System reviews, including Quality Management Review (QMR) and Annual Product Reviews (APRs) following commercial launch. You will work closely with our European CDMOs may also support the processing of European Product Complaints.

This role is based out of our Dublin, Ireland office location and will require up to 25% travel, including some international.

Your work will primarily encompass:

Batch Certification

• Ensure all manufacturing and testing activities comply with approved procedures, Investigational Medicinal Product Dossiers and regulatory standards
• Ensure that outsourced manufacturing and testing activities meet GMP and quality standards
• Act as the legally accountable person for batch certification (as per Directive 2001/83/EC, where applicable)
• Certify and release batches of medicinal products in accordance with EU GMP, Marketing Authorization (MA), and regulatory requirements

Supplier Quality Management

• In conjunction with U.S. based Compliance functions, provide Supplier and CSPs quality and compliance oversight
• Establish appropriate assessment mechanisms, risk-based controls, and monitoring and feedback loops to ensure compliant, effective oversight
• Serve as a resource for the conduct of audits and other assessments of both suppliers and business partners
• Process Supplier Corrective Action Requests (SCARs) and External Change Notifications (ECNs)

And will also include:

Inspection Readiness

• Establish and maintain the infrastructure and processes required to prepare Olema’s European affiliate for HPRA and other Competent Authorities of the European Union
• Utilize electronic systems, including Artificial Intelligence–enabled tools, to support inspection readiness activities
• Utilize Inspection Management Software to ensure consistent and reliable inspection preparation and response
• Perform Mock Inspections at European Suppliers / CSPs / Partners

Regulatory Intelligence and Monitoring

• Monitor local and European regulatory authorities for proposed GMP rulemaking and or trends in regulatory inspections
• Monitor inspectional status and compliance trends within the Olema European Supplier and CSP network

Annual Reviews and Quality System Leadership

• Participate in the annual Quality Management Review process
• Participate in the execution of Annual Product Quality Reviews upon commercial product launch
• Collaborate with Quality Systems to plan and deliver annual GxP topical training for relevant functions on European topics

As this is a new office, there may be other assignments and projects as required.

Ideal Candidate Profile >>>

A strong contributor with in-depth knowledge. A confident professional with a solid understanding of EU and UK regulatory GMP compliance requirements. A team-oriented individual with solid ability to communicate across multiple time zones, strong work ethic, optimism, and commitment to meaningful contributions. As such, we are looking for someone with the right combination of qualifications, knowledge, experience, and attributes for this role.

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.

Qualifications

• Eligible to act as a Qualified Person under EU legislation (Directive 2001/83/EC)
• Pharmaceutical Quality System (PQS) Auditor certification is highly preferred

Knowledge

• Bachelor's degree in pharmacy, chemistry, biology or a related scientific field is required
• Strong understanding of EU and Rest-of-World (ROW) regulatory and compliance requirements
• Demonstrated experience in Supplier Compliance and Inspection Management
• Firm knowledge of GMPs, GDPs and Quality Management Systems
• Experience using Inspection Management Software

Experience

• Minimum 10 years of experience in Biopharmaceutical industry
• Minimum 7 Years of experience in Supplier Quality Management
• Minimum 3 Years of experience with Oral Solid Dosage forms
• Minimum 4 Years of experience in a Qualified Person role
• Oncology experience is desirable

Attributes

• Self-directed and capable of independently setting and managing priorities
• Able to adapt to a rapidly changing organization characterized by ambiguity and evolving process definition
• Demonstrates strong cross-functional collaboration, and communication skills
• Comfortable adopting new technologies and tailoring them to Olema’s Quality and Compliance needs
• Critical thinking, able to identify the gates required for QP certification
• Passionate about meaningful work and contributing to patient-focused outcomes

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