ExM Quality Analytical Manager

EXM QUALITY ANALYTICAL MANAGER NEW BRUNSWICK, NJ Required Skills:

• Minimum B.A. or B.Sc. in life sciences .
• Ability to work independently and within team matrix environments .
• Ability to manage teams associated with individual aspects of responsibilities .
• Thorough knowledge of worldwide regulatory Good Manufacturing Practices (GMP) requirements and a working knowledge of Food and Drug Administration (FDA) & European Union (EU) GMP requirements .
• In depth knowledge of Quality Management Systems relating to laboratory operations .
• Ability to ensure objective critique of analytical investigation reports from CMOs or CLSs .
• Ability to manage business plus quality relationship with contract testing labs and support biological testing issues at CMOs .
• Previous experience in QC laboratory facing QA activities is highly desirable .
• Previous experience using electronic document and deviation management systems is desirable .
• Working knowledge of GMP Drug Substance environment is desirable .
• In-depth knowledge and operational experience at management level in a Pharmaceutical QC laboratory .
• DS and Drug Product experience .
• Strong knowledge of analytical technical transfer processes, compliance requirements and proven troubleshooting skills .
• Project Management skills are required .
• Strong technical knowledge of modern chromatographic methodologies. Knowledge of bioassay, peptide, and size exclusion chromatographic methods a distinct advantage .
• Management of Third Party relationships (desirable)

• This role is an opportunity to gain experience with Bulk Drug Substance manufacturing working in an external manufacturing environment within a Virtual Plant Team (VPT).
• The ExM Quality Analytical Manager will provide analytical support to the VPT.
• Provision of analytical expertise and troubleshooting support in the areas of biologics for the external manufacturing environment .
• Engage with internal and external stakeholders to plan and manage all testing of biological products at CMOs and CTLs .
• Represent Global External Manufacturing as the Quality Control (QC) laboratory subject matter expert in support of due diligence audits and for cause audits where laboratory related issues are a focus for such audits .
• Manage through team or individually review and approve all major laboratory investigations/Out of Specification (OOS) events at CMOs & CTLs.
• Provide technical support to the Qualified Person (QP)/ Responsible Person (RP) and Quality Operations in relation to same .
• Review and approve analytical change control documents associated with CMOs & CTLs or ensure said activities are done through team structure.
• Manage the communication flow to and from CMO analytical functions and global functions across the corporation, such as Global Testing Standards, RSCR (HQ) Reference Standards Management Team, Global Analytical Services, Global Regulatory Sciences, etc.
• Ensure review and approval of analytical method validation documentation & activities at CMOs and CTLs to determine compliance with International Council of Harmonisation (ICH) requirements and manage remediation of gap analysis at the organization or CLS .
• Provide analytical expert support for regulatory submissions .