Director, Quality Operations at Jobot
Raleigh, NC 27610
About the Job
REMOTE + Bonus + Equity + 401(k)
This Jobot Job is hosted by: Katie Griffith
Are you a fit? Easy Apply now by clicking the "Quick Apply" button and sending us your resume.
Salary: $190,000 - $220,000 per year
A bit about us:
We are a rapidly growing therapeutics company with an approved drug on the market, leveraging scientific advances in B-cell biology to develop novel treatment for patients.
Why join us?
Job Details
We are looking for a Director, Quality Operations to lead a small Lab QA team to support our biologics clinical development and commercial CMC programs including life cycle management. Our products span early to late-stage clinical development and commercial biologics manufactured by various contract development and manufacturing organizations.
RESPONSIBILITIES:
PROFESSIONAL QUALIFICATIONS:
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
This Jobot Job is hosted by: Katie Griffith
Are you a fit? Easy Apply now by clicking the "Quick Apply" button and sending us your resume.
Salary: $190,000 - $220,000 per year
A bit about us:
We are a rapidly growing therapeutics company with an approved drug on the market, leveraging scientific advances in B-cell biology to develop novel treatment for patients.
Why join us?
- Competitive Salary
- Annual Bonus
- Equity (RSUs)
- 401k
- Remote
- Approved drug
Job Details
We are looking for a Director, Quality Operations to lead a small Lab QA team to support our biologics clinical development and commercial CMC programs including life cycle management. Our products span early to late-stage clinical development and commercial biologics manufactured by various contract development and manufacturing organizations.
RESPONSIBILITIES:
- Provide Quality oversight of analytical testing services performed by CMOs, CTOs, and related GMP suppliers to resolve Quality issues and assure compliance with established procedures, cGMP, regulatory submissions, quality agreement, and other applicable guidelines and regulations
- Managing Lab QA resources to support all CMC programs (budget and personnel)Review analytical test results and reports, certificate of analyses, and raw data packets provided by CMOs and CTOs
- Author, review or approve certificate of analysis for drug substances, drug products, reference standards, or other GMP materials
- Review and approve major and critical analytical testing-related deviations, laboratory investigations for OOS, OOT, cleaning validation and other non-conforming or unexpected results, CAPAs, and change controls from CMOs and CTOs
- Create, document, manage, and/or approve analytical testing-related deviations, CAPAs, and change controls within the Quality Management System (QMS)
- Author, review, or approve analytical testing-related controlled documents, including but not limited to analytical methods, specifications, analytical and process validation protocols and reports, stability protocols and reports, and internal technical memos
- Develop and maintain internal processes and procedures for reference standard management to support all CMC programs, and provide quality oversight of clinical development phase and commercial stability programs
- Develop, maintain, and improve additional Lab QA processes to enhance effectiveness and efficiencies
- Provide guidance, advice, and support for GMP quality and compliance matters related to analytical testing and other related activities
- Support product complaint, stock recovery/product recall, field alert, biologic product deviation report and other quality events and regulatory actions as needed
- Prepare, review, or approve comprehensive reports or other quality and regulatory documents, i.e., stability reports, relevant CMC regulatory filings, and annual product quality reviews, etc.
- Serve as a Quality Lead of analytical testing suppliers with primary responsibility for ensuring suppliers are qualified and managed according to established procedures, cGMP, regulatory submissions, quality agreements, and other applicable guidelines and regulations.
- Perform and/or assist in Supplier Quality Audits for relevant GMP suppliers for analytical testing
- Create and maintain quality agreements with CMOs, CTOs and other GMP suppliers related to analytical testing in collaboration with other Quality Operations teams and Quality Systems group
- Support Customer Audits & Regulatory Inspections with on-site presence, as required
- Support inspection readiness activities internally, and at CMOs, CTOs and related suppliers
- Demonstrate high level of involvement in continuous improvement of internal, CMO and CTO quality assurance practices to ensure quality and compliance standards are maintained, and achieve Right First Time and Flawless Execution
- Contribute to development and continuous improvement of Quality Management System as relevant, such as creation and updating of Standard Operating Procedures (SOPs), etc.
- Develop and provide data integrity expertise to support all CMC programs
- Participate in developing, reporting, reviewing, and trending of GMP-related Quality Metrics such as Key Performance Indicators (KPIs)
- Driving a quality culture of excellence within biologics operations that is aligned with the organization's goals and objectives
- Travel to CMOs, CTOs and related suppliers, and our offices as required, to meet critical business needs; travel approximately 10% of time (domestic and international); the frequency of travel may increase for a short duration in order to meet critical business needs.
PROFESSIONAL QUALIFICATIONS:
- Minimum of 10 years’ experience in GMP QC/QA/Quality Systems, Microbiology or Analytical Development in biopharma/pharmaceutical industry
- Minimum of 5 years’ direct supervisory experience
- Hands-on experience in providing analytical/QC support for clinical and commercial manufacturing, tech transfers, product launches and ongoing commercial supplies
- Knowledge and expertise in principles and practices of cGMP for biologics, including manufacture and testing of drug substances and drug products
- Small molecule drug substance and solid oral dosage manufacturing experience is a plus
- Experience with CMO / CTO management (e.g., worked with or for CMOs / CTOs)
- Experience in working in a small biotech setting is a plus
- Broad working knowledge of global regulations (i.e., ICH guidelines, US FDA/EMA GMP regulations, etc.) for manufacturing, testing, packaging and distribution of drug substances and drug products
- Direct interaction with FDA, EMA or other regulatory agencies during regulatory inspections is a plus
- Demonstrated ability to broadly assess regulatory compliance audit findings and implement appropriate CAPAs at CMOs / CTOs
- Proficiency in electronic QMS software such as Veeva or TrackWise is a plus
- Excellent oral and written communication skills for effectively interfacing with internal and external organizations
- Effective leadership and managerial skills as well as the ability to manage multiple priorities with aggressive timelines and changing priorities
- Ability to troubleshoot, identify root causes and systematically resolve problems
- Ability to strategize (i.e., see ‘big picture’) and provide attention-to-detail when needed
- Direct interaction with EU/UK Qualified Persons (QPs) is a plus
Interested in hearing more? Easy Apply now by clicking the "Quick Apply" button.
Salary
190,000 - 220,000 /year