Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity. Working alongside a talented passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit us at
www.olema.com.
About the Role
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Associate Director GMP Quality
As the Associate Director GMP Quality reporting to the Director or GMP Quality you will be responsible for all GMDP activities pertaining to Olema’s products and clinical programs. In this position you will perform GMDP activities such as, but not limited to, Batch Disposition, Vendor compliance and overall quality management Olema’s products. In this role you will also collaborate with other functional teams such CMC, Regulatory and Supply Chain to ensure quality and compliance for Olema’s products.This role is based out of our
San Francisco
or
Boston
office and will require 10-15% travel.
Your work will
primarily
encompass:
- Batch disposition/ release for Clinical Trial Materials and Commercial batches
- Perform technical review and approvals Master Batch records and executed batch records
- Review and approval of Deviations, CAPA, Change Controls and Audit reports
- Perform technical review of Quality Control records such as Certificate of Release, Analytical Protocols and Reports and Stability reports
- Ensure appropriate Quality and Compliance oversight of Olema’s CMOs per quality agreements; this may include periodic visits to CMOs, as required
- Perform vendor /CMO audits
- Lead and support Pre-Approval Inspection readiness for NDA / commercial launch
- Prepare, manage and execute Quality Agreements
- Manage Qualified Person (QP) release of Clinical Trial Materials for EU
- Generate metrics and compile Quality Management data for Quality Management Reviews
- Coordinate and manage compliance related activities in preparation of regulatory and internal inspections and support interactions
- Provide Quality oversight and represent Olema on external CMO project teams. Manage relationships with CMOs
- Support and act as SME for Quality GMP for Regulatory inspections and audits
- Author Quality department SOPs as required
And will also include
:
- Efficient collaboration and communication with functional teams such as CMC, Supply Chain and Regulatory
- Timely escalation of critical quality and compliance issues to line management
- Manage critical quality issues with Vendors /CMOs and provide timely decisions
- Proactively identify gaps in existing process and procedures, and execute mitigations
Ideal Candidate Profile
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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:
- BA or BS degree in a scientific discipline with 10+ years of relevant industry experience
- (Preferred) Prior experience with NDA/BLA submission and commercial launch for pharmaceutical products
- (Preferred) Degree in chemistry or biology
Experience:
- 8+ work experience in an FDA regulated Pharmaceutical Industry with GMP experience
- Extensive understanding and knowledge of industry standards, concepts and current cGMP (21 CFR Part 210 and 211), Eudralex / EMEA , ICH and other agency standards and guidance as they relate to quality systems/quality assurance
- Experience with Health Authority filings
- Experience managing CMO relationships and supporting inspections Experience with Quality Management Systems such as Veeva or Trackwise or Master Control
- Proficient in Word, Excel, PowerPoint
Attributes:
- Demonstrates proven track record of leadership, communication, adaptability, and collaboration with both internal teams and external vendors
- Communicate decisions and recommendations with clear justification
- A strong team player with the ability to effectively communicate sound quality advice cross-functionally based on experience, regulations, and business needs
- Provide solutions to issues. Solutions are imaginative, thorough, practical, and consistent with Olema’s objectives
- Strategic thinking and ability to see the macro level
- Clear, concise writing skills and good verbal presentation skills
The base pay range for this position is expected to be $180,500 - $207,800 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.#LI-SB1
Important Information
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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.
Additional Note/Fraud Alert: Olema will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview. Though we use third party tools to help with advertising our jobs,
please be vigilant in checking that the communication is in fact coming from Olema.
