Associate Director, GMP Quality

Olema Oncology; Cambridge (MA); On-site; USD 160,000 - 180,000; Full time

Job summary

Olema Oncology is seeking an Associate Director, GMP Quality to oversee GMP activities for clinical and commercial products, including QA review of batch records and supplier compliance. This role partners with CMC, Regulatory and Supply Chain, and will be based in SF or Boston with travel.

The ideal candidate has 8+ years in FDA-regulated pharma GMP QA, experience with NDA/BLA submissions, and strong leadership and communication skills.

Qualifications

• Bachelor’s degree required; advanced degree preferred (MS/PhD/ PharmD).
• Deep knowledge of cGMP (21 CFR Parts 210/211), ICH Q7 and related guidance.
• Experience with NDA/BLA submissions and commercial launches.
• Experience with Quality Management Systems and investigations.
• Familiarity with Health Authority filings and EU QP queries.
• Experience managing CMO relationships and inspections.
• Proficient in MS Office (Word, Excel, PowerPoint, SharePoint).
• Strong leadership, communication and collaboration skills.

Responsibilities

• Batch disposition and release oversight for Clinical Trial Materials and Commercial batches.
• Technical review of Quality Control records and Master/Executed Batch records.
• Review of Deviations, CAPA, Change Controls; internal shadow records when needed.
• Support NDA/BLA submissions and pre-approval inspections readiness.
• Coordinate with CMC/Regulatory/Supply Chain to ensure compliance.
• Interact with Qualified Persons to facilitate releases.
• Generate metrics for Quality Management Reviews and Annual Product Quality Reviews.

Skills

Leadership

Communication

Adaptability

Collaboration

Education

Bachelor’s degree; advanced degree preferred

Tools

Veeva

TrackWise

Microsoft Office

Job description

Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. It’s an exciting time to be part of Team Olema, with our transformation into a fully integrated oncology company well underway, top-line data from our lead program expected later this year, and our first potential commercial launch on the horizon.

Our lead product candidate, palazestrant, is a novel, orally available complete estrogen receptor antagonist (CERAN) and selective estrogen receptor degrader (SERD) currently in two pivotal Phase 3 clinical trials. We expect top-line data from OPERA-01, our ongoing Phase 3 trial of palazestrant as a monotherapy in patients with second- or third-line ER+/HER2- metastatic breast cancer (MBC), in the fall which, if successful, could lead to our first potential approval and commercial launch in 2027. OPERA-02, our Phase 3 trial of palazestrant in combination with ribociblib in patients with frontline ER+/HER2- MBC, is enrolling patients. Together with its mechanism of action, pharmacokinetic properties, and the potential to demonstrate activity in both ESR1 wild-type and mutant tumors, palazestrant has the potential to transform the metastatic breast cancer treatment paradigm and access a $15 billion global market opportunity.

Our follow-on product candidate, OP-3136, is a potent KAT6 inhibitor with the potential to generate further value and meaningfully impact the metastatic breast cancer treatment landscape – particularly in combination with palazestrant. We recently reported encouraging Phase 1 monotherapy data from this program across multiple solid tumor types and are advancing patient enrollment in the ongoing combination arms in MBC.

Aspiring to transform the metastatic treatment paradigm is an ambitious endeavor that requires a resolute approach to developing better therapies and a passionate team dedicated to helping the patients we serve feel better, longer. We possess a deep commitment to our shared purpose, the sustained pursuit of excellence, cultivating the courage required to advance our programs, drive to succeed, and a collective capacity for adaptability through learning, growth, and evolution. Team Olema is made up of nimble self-starters who bring consistency in their quest for the extraordinary every single day.

If you’re ready to be part of a tenacious, courageous, agile, and growing team, join us in making a profound impact, together – for our patients, for your career, and for what’s beyond

About the Role

As the Associate Director, GMP Quality, reporting to the Head of GMP Quality, you will be responsible for oversight of GMP activities pertaining to Olema’s products, both clinical and commercial. The focus of this role will be oversight of the manufacture of small molecule drug substances (Active Pharmaceutical Ingredients). There will be associated responsibilities for reviewing Analytical Development / Quality Control results. In this position you will perform GMP activities such as, but not limited to, review of Certificate of Analysis, Batch Disposition, Person in Plant oversight, and supporting Supplier compliance. In this role you will also collaborate with other functional teams such CMC, Regulatory and Supply Chain to prepare submissions, ensure quality and compliance for Olema’s products.

This role will be based out of our San Francisco or Boston office and will require 10-15% travel, some international.

Your work will primarily encompass:

• Batch disposition/ release for Clinical Trial Materials and Commercial batches
• Perform technical review, quality oversight and approvals Master Batch records and Executed Batch records
• Review and approval of CMO Deviations, CAPA, and Change Controls and opening of internal shadow records when required
• Perform technical review of Quality Control records such as Certificate of Analysis, Analytical Testing, Method Validation and Stability reports
• Operational oversight of Olema’s CMOs as specified in quality agreements; this may include periodic visits to CMOs
• Represent Olema as Person in Plant (PIP) when critical processing occurs as necessary
• Support Pre-Approval Inspection readiness for NDA / commercial launch
• Review sections of New Drug Applications for content and accuracy
• Review Quality Agreements and support Supplier audits as necessary
• Interact with Qualified Persons (QP) to facilitate the release of Clinical and Commercial product
• Generate metrics for Quality Management Reviews
• Contribute and participate in Annual Product Quality Reviews of commercial products
• Represent GMP Quality during internal and regulatory inspections
• Author Quality department SOPs as required

Ideal Candidate Profile

We are looking for someone with the right combination of knowledge, experience, and attributes for this role.

Knowledge

• Bachelor’s degree is required; advanced degree (MS, PharmD, PhD) preferred
• Extensive understanding and knowledge of industry standards, concepts and current cGMP (21 CFR Parts 210 and 211), EudraLex Volume 4, ICH Q7 and other agency standards and guidance as they relate to GMP Quality Assurance

Experience

• Minimum of 8 years' work experience in an FDA regulated Pharmaceutical GMP / GMP QA role
• Experience with small molecule synthesis and analytical test record review
• Prior experience with NDA/BLA submission and commercial launch for pharmaceutical products
• Familiarity with effective Quality Systems and performing robust investigations
• Experience with Health Authority filings and EU QP queries
• Experience managing CMO relationships and supporting CMO inspections
• Experience with Quality Management Systems such as Veeva or TrackWise
• Proficient in Word, Excel, PowerPoint, SharePoint

Attributes

• Demonstrated proven track record of leadership, communication, adaptability, and collaboration
• Communicate decisions and recommendations with clear background and justification
• A strong team player with the ability to focus on project objectives with an emphasis on quality
• Clear, concise writing skills and good verbal presentation skills
• Ability to prioritize, work independently, and mindfully engage with others

The base pay range for this position is expected to be $160,000 - $180,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

Important Information

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 Oncology and 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 olev.com; our careers page is olev.com/careers; our LinkedIn page is linkedin.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 payments of any kind, and does not make job offers without an in-person interview.