Quality Assurance Director- CMC

Exemplify Biopharma, Inc., a Symeres Company; Cranbury Township (NJ); On-site; USD 120,000 - 150,000; Full time

Job summary

Ein innovatives Unternehmen sucht einen erfahrenen Quality Assurance Director, der mit einer Leidenschaft für die Entwicklung von Lösungen in der Pharmaindustrie dazu beiträgt, die Qualität und Compliance in der CMC-Entwicklung sicherzustellen. In dieser Schlüsselrolle sind Sie verantwortlich für die Implementierung von Qualitätssystemen und die Überwachung der regulatorischen Anforderungen. Sie werden eng mit interdisziplinären Teams zusammenarbeiten, um sicherzustellen, dass alle Prozesse den höchsten Standards entsprechen. Wenn Sie eine Leidenschaft für Qualitätssicherung haben und in einem dynamischen Umfeld arbeiten möchten, ist dies die perfekte Gelegenheit für Sie.

Benefits

Gesundheitsversicherung

Zahnversicherung

401K-Rentenplan

Bezahlter Urlaub

Qualifications

• Mindestens 8 Jahre Erfahrung in Qualitätssicherung für kleine Moleküle.
• Direkte Erfahrung in der Herstellung von Arzneimitteln.

Responsibilities

• Entwicklung und Implementierung von Qualitätssystemen und Verfahren.
• Überwachung der Qualitätssicherung und regulatorischen Compliance.

Skills

Qualitätssicherung

Regulatorische Compliance

Analytische Fähigkeiten

Problemlösungsfähigkeiten

Kommunikationsfähigkeiten

Education

Bachelor in Chemie

Master in Biochemie

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.

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 [e-mail].

• Pharmaceutical Manufacturing

Employment Type

• Full-time

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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