Quality Assurance Director- CMC

Job description

Exemplify BioPharma, Inc., a Symeres Company is a global partner research organization (PRO) based in New Jersey, USA. We are a team of biopharma industry experts focused on delivering end-to-end Chemistry, Manufacturing and Controls (CMC) throughout the drug development and regulatory market application processes. Using a unique combination of program management, coupled with our New Jersey based process development laboratories we are ideally positioned to deliver CMC success to partner organizations. We are talent based team and our key asset is our experience, multidisciplinary expertise and proven track record. We strive to bring tangible value to our partners through provision of strategic, tactical and technical leadership to solve complex problems focused on reducing program timelines and costs.

Job Summary

We are seeking an experienced Quality Assurance Director with at least 8 years of experience in CMC development of small molecule NCE’s in the pharmaceutical industry. The successful candidate will be responsible for developing, implementing and overseeing all aspects of quality assurance and regulatory compliance for our early stage, preclinical through phase 2, CMC development services business.

Key Responsibilities

• Develop and implement quality systems and procedures, in alignment with existing company policy, to ensure compliance with all applicable regulations and standards, including FDA and EU GMP and ICH guidelines with a primary focus on early stage development from preclinical through phase 2.
• Build and develop a robust QMS including planning and overseeing the transition from a paper-based quality system to an electronic based QMS and ensure its ongoing effectiveness for our CMC development CRO services.
• Oversee the preparation, review and approval of all manufacturing documents, testing and stability protocol and reports, specification (raw materials, in-process, intermediates, finished product, stability), and packaging documents for drug substance and drug product, including associated change controls, investigations (deviations, out-of-specification (OOS)/out-of-trend (OOT)), CAPA, and analytical raw data, to ensure compliance with established procedures and specifications.
• Collaborate with cross-functional teams, including R&D, drug substance and drug product manufacturing to ensure alignment and consistency in quality standards and processes.
• Monitor and analyze quality metrics and provide recommendations for continuous improvement.
• Represent Exemplify as first contact point for the quality assurance function with client teams and regulatory agencies when and as necessary.
• Serve as the primary point of contact for clients’ inspections and audits.

Qualifications

• Bachelor's or advanced degree in a relevant scientific field, such as chemistry, biochemistry, or pharmacy.
• Minimum of 8 years of experience in CMC quality assurance and regulatory compliance for small molecule NCE development in the pharmaceutical or contract research industry.
• Direct hands-on direct experience in bulk drug substance and finished drug product manufacture.
• Strong knowledge of FDA, EU GMP, and ICH guidelines related to stability (Q1A-Q1F), Analytical Validation (Q2), and Specifications (Q6A-Q6B), especially as it pertains to pre-clinical and Phase 1 CMC activities.
• Excellent written and verbal communication skills, with the ability to communicate complex information clearly and effectively.
• Strong analytical and problem-solving skills, with the ability to identify issues and develop effective solutions.
• Experience working in a client facing role including liaising with clients to address project specific requirements, and the development of QTA’s and quality agreements.
• Hands on experience as the primary point of contact for clients’ quality inspections and audits.
• Experience in the preparation and submission of regulatory filings, including INDs, and NDAs is a plus.

Benefits

Exemplify offers a competitive salary and total benefit package including health, dental, vision, life and short-term disability insurance through APD, including a 401K retirement saving’s plan, and paid time off.

Application

If you are an experienced Quality Assurance Director with a passion for developing innovative solutions in the pharmaceutical industry, we would love to hear from you. Please submit your resume and cover letter to careers@exemplifybiopharma.com.

Industry

• Pharmaceutical Manufacturing

Employment Type

• Full-time