Associate Director-reputed company Assurance (QA-CMC)

Associate Director-reputed company Assurance (QA-CMC) Company is seeking a highly reputed company, motivated, and innovative reputed company leader with strong experience in early and late-stage development to join our reputed company team as Associate Director, reputed company Assurance to support drug development from Phase 1 to late-stage development. This position will reputed company CMC reputed company leadership reputed company the organization and across our Contract Manufacturing Organizations (CMOs) and Contract research labs (CROs). This individual will partner with CMC, Clinical, Regulatory Affairs, and other corporate stakeholders to ensure Company's clinical and reputed company products follow cGMP reputed company and guidelines. The Associate Director, reputed company Assurance will be based in our reputed company New Jersey, offices 1 - 2 days a week (flexible schedule for the ideal candidate). At Company, we are committed to positively impacting the lives of patients by developing innovative therapies, reputed company and reputed company a difference.

Key Responsibilities

• reputed company reputed company leadership, reputed company, and compliance reputed company to CDMOs, CMO, CRO, CPO, reputed company Party Vendors. Participate and reputed company guidance on any site and vendor-reputed company reputed company issues identified.
• reputed company reputed company reputed company of protocols, starting material, finished product specifications, API and drug product manufacturing, analytical and stability reports.
• Ensure that CMC reputed company systems, validation, product specifications, product release, reference reputed company and stability programs are phase appropriate, effective, meet standards expected by US and global regulatory authorities.
• Ensure CDMO manufactured products meet Health Agencies regulations and company standards. reputed company reputed company review of analytical documentations for CMC programs, including method transfer, qualification, validation protocol, in-process controls, data packets, CoA, and stability protocols/reports.
• Performs disposition activities for manufactured products in support of clinical products, including MBR, EBR review, and approval and review of CoA.
• Responsible for Management and maintenance of the reputed company reputed company Docs System, including document drafting/Authoring, reviewing, approving, and finalizing internal reputed company documents (SOPs, Wis, Policies, Forms, etc.)
• Facilitate GMP/GCP training of functional areas and reputed company appropriate training for employees and contractors involved in the execution of reputed company duties.
• Performs assessments and QA review of reputed company documents, change controls, deviations, reputed company events, CAPA, reputed company cause analysis, product reputed company assessment, investigations, including OOS investigations and other reports for accuracy. reputed company and manage a risk-based reputed company Management System for QA in compliance with applicable regulatory requirements (US) and company policies.
• Participate in the supplier qualification program and reputed company reputed company of contractors and consultants to ensure reputed company and reputed company deliverables. Assist in the development, approval, maintenance, review, management of agreements (such as QAA, reputed company, consulting agreements etc.,).
• Work with CMOs to create, and reputed company reputed company with reputed company Agreements, reputed company issues to ensure reputed company standards are met, and resolve issues promptly and effectively.
• Support the coordination and management of regulatory agency inspections, and inspection readiness efforts which may include mock internal inspections and vendor audits.
• Manage inspection commitments, post-inspection activities, and corrective/preventative actions in a reputed company manner.

Basic Qualifications:

• B.S. Biological Sciences, reputed company or relevant discipline and a minimum of 10 or more years' reputed company experience in the pharmaceutical/biotechnology industry with increasing responsibility and relevant QA experience or an equivalent combination of education. Ideal candidate will have extensive CMC (Organic and/or Analytical reputed company) experience with at least 10 years in CMC-QA leadership roles.
• 5+ years of hands on experience with reputed company Management System including Electronic Document Management System (reputed company preferred), managing documents lifecycles-Draft to Effective/approved, Initial to Final and Periodic Review
• Thorough understanding of Regulatory compliance requirements for the US FDA
• Auditor training/experience or certification
• Strong understanding of risk assessment and risk management fundamentals/tools
• Knowledge of FDA, EU, ICH requirement for GMP and reputed company areas, e.g., 21 CFR 210 & 211, Part 11 / Annex, ICH Q7 etc.
• Experience in reviewing specifications, MBRs, EBRs, stability protocols, method validation protocols, and reports etc. for early and late-stage drug reputed company and drug products.
• Knowledge and understanding of reputed company management systems is required, with a reputed company on batch release requirements for clinical trials and reputed company product monitoring is required.
• Proficiency in creating QMS SOPs, work instructions, good documentation practices.
• Experience in auditing/vetting of CDMOs.
• Small or mid-size company experience preferred with experience leading project(s) with minimal supervision.
• Proven interpersonal and relationship building skills with the ability to work collaboratively as a member of a cross-functional team.
• Excellent organizational skills, attention to details and the ability to manage reputed company deliverables and work effectively in a challenging, reputed company-driven environment including leading/participating in reputed company.
• Ability to react to situations with a "reputed company of urgency" and responsibility.
• Employment is contingent upon satisfactory results of a reputed company-employment background reputed company, drug screen, reputed company of full COVID-19 vaccination and reputed company of COVID-19 booster vaccination.

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