Sr. Manager, Quality Operations

Job Scope

The Senior Manager, Quality Operations is responsible for Manufacturing & QC Shop-Floor Quality, Batch Release, Document Control, and Training functions. He /She oversees the group responsible for quality functions related to Good Manufacturing Practices (GMP) and Phase-Appropriate compliance for both clinical and marketed Gene Therapy products and Plasmid DNA at the Hopewell manufacturing facility. He /She is expected to grow and develop the group commensurate with the business need.

Essential Responsibilities:

Lead Probio Quality Operations and Batch Release Program for Gene Therapy and Plasmid Manufacturing. This may include, but may not be limited to the following functions:

• Develops procedures for and performs local batch disposition for Gene Therapy Drug Substance, Drug Product, MCB (Master Cell Bank), Plasmid and Finished goods manufactured at the Hopewell, NJ site.
• Issues batch compliance documentation such as Certificates of Conformance/ Compliance / Quality (CoCs/COQs), Certificates of Analysis (CoAs), BSE/TSE Statements.
• Develops and manages QA functions related to Cell Bank and Plasmid disposition, usage, and lifecycle.
• Oversees ProBio QA Area Release/ Line Clearance Procedures and facility walkthroughs.
• Oversees the QA approval of calibration reports for GMP equipment/instruments in Maximo
• Supports internal and external audits to assure compliance with GMP regulations.
• Manages or performs QA “person-in-plant” type activities during cell bank receipt, manufacturing, filling, labeling, visual inspection, packaging, warehousing and shipping activities.

Directs Document Control, Records Management & training activities for the Gene Therapy Manufacturing Site Activities. This may include, but may not be limited to the following functions:

• Oversees Document control activities related to approval of local electronic documents such as SOPs, Standards, Forms, Work Instructions, Master Batch Records, and specifications.
• Develops and implements local procedures for control of drug product label proofs, printed labels, and reconciliation of unused/damaged labels.
• Manage Veeva Vault administration for all Veeva Vault applications.
• Supports interactions with regulatory authorities related to manufacturing quality and compliance policies, guidelines, and systems.
• Recommends Quality system changes to enhance overall job performance and Quality functions and partners with peers in overseeing the implementation of these changes.

Qualifications:

• Bachelor’s degree in a scientific discipline and a minimum 7 years of experience in Quality or related role(s) in a pharmaceutical, biotechnology or related environment, and at least 3 of which have been in a CMC-focused Quality position.
• Experience with Veeva Vault Quality Docs and Training
• Proficiency with Microsoft Office.
• Excellent verbal and written communication skills.
• Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Demonstrated knowledge of biologics, viral vector, and plasmid manufacturing and testing.           

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