Associate Director, GMP Quality Assurance - Qualified Person
Dublin, Ireland
Olema Oncology is dedicated to developing better medicines for breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a complete estrogen receptor antagonist (CERAN) currently in development for metastatic breast cancer with blockbuster potential as a monotherapy and in combination in ER+/HER2- metastatic breast cancer. Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with best-in-class potential.
Our scientific breakthroughs are accelerated through the ways in which we fearlessly support, motivate, and challenge one another. At Olema, we know that when we put people first, our work becomes second to none. If you’re ready to join us at the edge of something unstoppable, let’s make a profound impact together for our patients, for your career, for what’s beyond.
You can view our latest corporate deck and other presentations here .
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 forsomeone 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
We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience. Olema is building a culture where the value of difference is celebrated.
We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers. A Summary of Benefits is available for all applicants.
Please note: Olema doesn’t accept agency resumes and is not responsible for any fees related to unsolicited resumes. Thank you.
Fraud Alert : We are aware of employment scams where individuals pose as representatives of Olema Oncologyand make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is olem.com ; our careers page is olem.com/careers ; our LinkedIn page islinkedin.com/company/olema-oncology .Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront paymentsof any kind, and does not make job offers without an in-person interview.
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