Associate Director-Quality Assurance
3 days ago
Company is seeking a highly experienced, motivated, and innovative quality leader with strong experience in early and late-stage development to join our Quality team as Associate Director, Quality Assurance to support drug development from Phase 1 to late-stage development. This position will provide CMC quality leadership within 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 commercial products follow cGMP framework and guidelines. The Associate Director, Quality Assurance will be based in our Northern 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, come join us and make a difference.
Key Responsibilities
- Provide quality leadership, strategy, and compliance oversight to CDMOs, CMO, CRO, CPO, Third Party Vendors. Participate and provide guidance on any site and vendor-related quality issues identified.
- Provide Quality oversight of protocols, starting material, finished product specifications, API and drug product manufacturing, analytical and stability reports.
- Ensure that CMC quality systems, validation, product specifications, product release, reference standard and stability programs are phase appropriate, effective, meet standards expected by US and global regulatory authorities.
• 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 Veeva Quality Docs System, including document drafting/Authoring, reviewing, approving, and finalizing internal quality documents (SOPs, Wis, Policies, Forms, etc.)
- Facilitate GMP/GCP training of functional areas and develop appropriate training for employees and contractors involved in the execution of related duties.
• Participate in the supplier qualification program and provide oversight of contractors and consultants to ensure timely and quality deliverables. Assist in the development, approval, maintenance, review, management of agreements (such as QAA, MSD, consulting agreements etc.,).
- Work with CMOs to create, and keep current with Quality Agreements, Quality issues to ensure quality 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 timely manner.
- B.S. Biological Sciences, Chemistry or relevant discipline and a minimum of 10 or more years' related 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 chemistry) experience with at least 10 years in CMC-QA leadership roles.
- 5+ years of hands on experience with Quality Management System including Electronic Document Management System (Veeva 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
• Experience in reviewing specifications, MBRs, EBRs, stability protocols, method validation protocols, and reports etc. for early and late-stage drug substance and drug products.
• Knowledge and understanding of quality management systems is required, with a focus on batch release requirements for clinical trials and commercial 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 concurrent deliverables and work effectively in a challenging, milestone-driven environment including leading/participating in projects.
• Ability to react to situations with a "sense of urgency" and responsibility.
• Employment is contingent upon satisfactory results of a pre-employment background check, drug screen, proof of full COVID-19 vaccination and proof of COVID-19 booster vaccination.
An Equal Opportunity Employer
-
Director of Nursing
2 weeks ago
Jersey City, NJ, United States Roljobs Technology Services Pvt Ltd Full timeWe are currently on a hunt for a Director of Nursing to join our team in Jersey City. What you’ll be doing: You will be responsible for development and implementation of nursing objectives, a nurse staffing plan, participation in the annual budget and financial objectives,quality assurance plan for nursing services. You provide nursing services in...
-
Director, Control Testing and Assurance
5 days ago
Jersey City, NJ, United States Royal Bank of Canada Full timeJob Description What is the opportunity? Global IT Risk (GITR) is part of RBC's Technology and Operations division. It enables the protection of RBC's brand, systems, and operations by equipping technology partners with meaningful actions, insights, actionable advice, and information on RBC IT & Cyber risks. Join our dynamic team as a "Director, Control...
-
Director, Control Testing and Assurance
3 days ago
Jersey City, NJ, United States Royal Bank of Canada Full timeJob Description What is the opportunity? Global IT Risk (GITR) is part of RBC's Technology and Operations division. It enables the protection of RBC's brand, systems, and operations by equipping technology partners with meaningful actions, insights, actionable advice, and information on RBC IT & Cyber risks. Join our dynamic team as a "Director, Control...
-
Senior Director, Regulatory Affairs
20 hours ago
Jersey City, NJ, United States Eikon Therapeutics Full timeEikon Therapeutics is a new biopharmaceutical company employing revolutionary technology at the intersection of chemistry, engineering, computation, and biology to discover novel treatments for life-threatening diseases. Eikon's discovery platform is built on groundbreaking innovations from its founders (Nobel Prize, 2014), culminating in the creation of...
-
Jersey City, NJ, United States Organon Full timeJob Description Position Overview The Associate Director is responsible for ensuring that Primary Market Research, Competitive Intelligence, and Data Analytics is conducted in an ethical and compliant manner in accordance with the laws, regulations, Company policies and procedures, and governing body rules and standards. The Associate Director will: Be a...
-
Senior Compliance Assurance Analyst
2 weeks ago
Jersey City, NJ, United States Royal Bank of Canada Full timeJob Description What is the Opportunity? Execution of Compliance Quality Assurance activities in accordance with the 2LOD Compliance Quality Assurance Program. The Quality Assurance team is responsible for monitoring and testing of compliance activities performed by the First and Second Lines of Defence, reviewing the design and implementation of policies,...
-
Senior Compliance Assurance Analyst
1 day ago
Jersey City, NJ, United States Royal Bank of Canada Full timeJob Description What is the Opportunity? Execution of Compliance Quality Assurance activities in accordance with the 2LOD Compliance Quality Assurance Program. The Quality Assurance team is responsible for monitoring and testing of compliance activities performed by the First and Second Lines of Defence, reviewing the design and implementation of policies,...
-
Senior Compliance Assurance Analyst
1 week ago
Jersey City, NJ, United States Royal Bank of Canada Full timeJob Description What is the Opportunity? Execution of Compliance Quality Assurance activities in accordance with the 2LOD Compliance Quality Assurance Program. The Quality Assurance team is responsible for monitoring and testing of compliance activities performed by the First and Second Lines of Defence, reviewing the design and implementation of policies,...
-
Senior Compliance Assurance Analyst
5 days ago
Jersey City, NJ, United States Royal Bank of Canada Full timeJob Description What is the Opportunity? Execution of Compliance Quality Assurance activities in accordance with the 2LOD Compliance Quality Assurance Program. The Quality Assurance team is responsible for monitoring and testing of compliance activities performed by the First and Second Lines of Defence, reviewing the design and implementation of policies,...
-
Senior Compliance Assurance Analyst
7 days ago
Jersey City, NJ, United States Royal Bank of Canada Full timeJob Description What is the Opportunity? Execution of Compliance Quality Assurance activities in accordance with the 2LOD Compliance Quality Assurance Program. The Quality Assurance team is responsible for monitoring and testing of compliance activities performed by the First and Second Lines of Defence, reviewing the design and implementation of policies,...
