Director, Quality Operations
Nimbus has an outstanding opportunity for an exceptional Director of Quality Operations to join our team. This role will be responsible for leading and managing the strategic and operational performance of the Quality function ensuring the successful delivery of business strategy, Key Performance Indicators (KPIs) and objectives, while adhering to regulatory compliance.
In this role, you will:
• Develop and implement the Quality function to ensure it meets the business requirements, as well as ensure functional performance against objectives.
• Implement and maintain all Quality systems to ensure compliance with applicable regulations/guidelines covering GCP/GMP/GxP for Investigational Medicinal Products (IMPs) for human use.
• Implement and maintain a Quality Risk Management System to ensure that risks are adequately addressed/mitigated.
• Act as the main point of contact for all Quality matters, internally and externally.
• Ensure the development of appropriate SOPs (writing/revising/approving), ensuring regulatory compliance in conjunction with being “fit for purpose” operationally.
• Ensure all activities are performed in accordance with GCP/GMP/GxP, company SOPs, applicable laws and regulations.
• Ensure supplier and subcontractor audits are performed and reported, as scheduled.
• Manage all validation activities, including validation strategy, approval of protocols and reports.
• Maintain awareness of new and proposed regulations and guidelines that may impact the business; communicate those changes to the Senior Management Team as needed.
• Prepare, review, and approve Technical and Quality Agreements.
• Ensure appropriate investigation of discrepancies, errors, complaints, failures, or adverse events requiring documented review and action (if necessary, interrupting processes causing material to be quarantined or placed on hold until matters are resolved).
• Coordinate regulatory authority inspections as needed.
These Qualifications Will Help This Role Be Successful:
• Scientific degree (ideally pharmacy, pharmaceutical sciences, chemistry or related).
• 10+ years of professional quality experience within GCP/GMP/GxP within a drug development environment.
• Demonstrated track record leading a robust and efficient Quality function, with an emphasis on GCP/GMP/GxP compliance.
• Strong knowledge of US & International regulations and guidelines, as well as deep understanding in fundamental principles and practices of drug development.
• Proven ability developing and advancing progressive quality operational models, systems, and frameworks
• Experience developing robust and compliant SOPs according to GxP guidelines and regulatory authority requirements.
• Current knowledge of industry trends and best practices for progressive quality management within a regulated environment.
• Experience/training in process development/improvement (e.g., Lean Six Sigma).
A Snapshot of Nimbus
At Nimbus, we design breakthrough medicines. Utilizing our powerful structure-based drug discovery engine, we create potent and selective small molecule compounds targeting proteins that are known to be fundamental drivers of pathology in highly prevalent human diseases and which have proven difficult for other drug makers to tackle. With a decade-plus track record of success, we’ve built a world-class team in both computationally driven drug discovery and early clinical development while continuing to move the needle for patients.
Nimbus is a close-knit company (our employees are Nimbi, if you are curious!) that values a fast-paced, entrepreneurial, intellectual-stimulating, and collaborative environment. We live by our Core Values: Integrity, a Passion for Excellence, Teamwork, and Authentic Communication and strive to build a community where we bring out the best in each other professionally and personally.
Founded in 2009, Nimbus is a private, growing biotechnology company headquartered in Cambridge, Massachusetts. Learn more about us by going to www.nimbustx.com
Join Nimbus. We are making a difference and you can too.
Nimbus is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. Nimbus does not accept unsolicited resumes from any source other than directly from candidates.