About the Role >>> Associate Director GMP Quality

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 >>> Key Requirements

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.

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.

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