Urgent! Associate Director-Quality Assurance (QA-CMC) Job Opening In Jersey City – Now Hiring 7SolutionsUSA
Associate Director-Quality Assurance (QA-CMC)
Salary Range: $1 to $2 Per Year
Associate Director-Quality Assurance (QA-CMC)
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
·Ensure CDMO manufactured products meet Health Agencies regulations and company standards.
Perform quality 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.
·Performs assessments and QA review of source documents, change controls, deviations, quality events, CAPA, root cause analysis, product impact assessment, investigations, including OOS investigations and other reports for accuracy.
Develop and manage a risk-based Quality Management System for QA in compliance with applicable regulatory requirements (US) and company policies.
·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.,).
Basic Qualifications:
·Knowledge of FDA, EU, ICH requirement for GMP and related 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 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.
·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
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Unlock Your Associate Director Potential: Insight & Career Growth Guide
Real-time Associate Director Jobs Trends in Jersey City, United States (Graphical Representation)
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Great news! 7SolutionsUSA is currently hiring and seeking a Associate Director Quality Assurance (QA CMC) to join their team. Feel free to download the job details.
Wait no longer! Are you also interested in exploring similar jobs? Search now: Associate Director Quality Assurance (QA CMC) Jobs Jersey City.
An organization's rules and standards set how people should be treated in the office and how different situations should be handled. The work culture at 7SolutionsUSA adheres to the cultural norms as outlined by Expertini.
The fundamental ethical values are:The average salary range for a Associate Director Quality Assurance (QA CMC) Jobs United States varies, but the pay scale is rated "Standard" in Jersey City. Salary levels may vary depending on your industry, experience, and skills. It's essential to research and negotiate effectively. We advise reading the full job specification before proceeding with the application to understand the salary package.
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Before the Interview:To prepare for your Associate Director Quality Assurance (QA CMC) interview at 7SolutionsUSA, research the company, understand the job requirements, and practice common interview questions.
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