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Our Client is searching for a dynamic Manager GMP QA - Clinical to join a growing QA team. Looking for someone who cares about this important work, and who's driven to connect to our mission of helping these patient communities. The Manager GMP QA Clinical will be responsible for supporting and maintaining high quality levels on company Drug Substance, Drug Product, packaged Drug Products and finished goods by Contract Manufacturing Organizations (CMOs). This Quality Assurance professional must possess strong leadership skills in order to provide support to the QA Clinical team, and will assure the company, its affiliates and/or contractors associated with the manufacture, packaging, labeling, testing and distribution of products used for investigational clinical trials through commercial phases comply with cGMPs and standards as well as regulations of applicable authorities. This role will report to the Associate Director, GMP Quality Assurance and be a member of the GMP clinical group.

RESPONSIBILITIES

Conduct product release activities mainly for packaged drug product and finished goods for all phases of development including review and approval of master batch records and executed batch records.Provide onsite oversight/monitoring of manufacturing campaigns as appropriate.Coordinate QP release as appropriate.Work collaboratively with key stakeholders on drug packaging/labeling strategies and plans to ensure investigational product releases within timelines. Organize and coordinate QA operational packaging and labeling resources and schedule. Effectively interact with external contract packagers/labelers and ID testing laboratories as well as work as part of an internal multidisciplinary team to support packaging/labeling, testing, and product complaint investigations.Work with CMOs to raise, investigate and resolve deviations and investigations prior to lot disposition.Effectively interact with external contract manufacturers and testing laboratories as well as work as part of an internal multidisciplinary team to conduct, review and approve manufacturing, testing, and product complaint investigations.Assist in preparing or reviewing CMC sections of regulatory submissions.Manage and address associated Investigations, CAPAs, Change Controls, Material Review Boards, OOS, etc.Implement necessary Quality Agreements.Represent the QA department on project teams.Conduct audits of CMOs, Testing Laboratories, or any other services such as labels, etc.

REQUIREMENTS

Bachelor's degree in biology, chemistry, life sciences or a related field.Minimum 5+ years' experience of Quality Assurance experience in a cGMP manufacturing environment. Experience related to global clinical packaging and labeling is a plus. Strong attention to detail, and quality of work skills is a plus.Excellent time management skills with a proven ability to meet deadline.Strong knowledge of cGMP regulations, practices and trends pertaining to pharmaceutical product development, manufacturing, testing, clinical operations and handling quality reports and documentation.Exercises judgment within broadly defined practices and policies in determining solutions and actions.Demonstrates ability to identify and recognize critical decisions that will result in delays in schedule or operations that may jeopardize overall business activities.Knowledge of drug substance, drug product and solid dosage manufacturing principles, equipment, and processes.Proficiency using Office 365, electronic document system (Veeva), Smartsheet, electronic inventory system and Adobe Acrobat.

P1402382BOSJB_1736264357 To Apply for this Job Click Here