Mgr, Quality Assurance

Job Description

Our Company has constructed a new manufacturing facility to significantly expand its production capacity. Global demand has outpaced our current maximum manufacturing capabilities. Once this new facility is fully operational, we will triple our current manufacturing capacity, which is expected to support the anticipated demand for the foreseeable future. This investment reaffirms our Company’s longstanding dedication to producing this medicine for the patients who need it. The facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.

The Quality Assurance Manager will direct Shop Floor Quality Assurance (SFQA) B160 to support process and technology introduction, compliance improvements, and manufacturing readiness to initiate production of commercial product.  The focus for the position includes all aspects of Shop Floor QA oversight supporting Second Shift (Evening Shift).

Responsibilities

• Reporting to the Quality Assurance Organization, will independently manage Shop Floor Quality Assurance team on second shift.
• Lead a Shop Floor QA team to provide end-to-end QA support for Production Support & Media, Drug Substance and Drug Product throughout the project lifecycle.
• Ensure all aspects of the Shop Floor QA proceed in compliance with cGMP, regulations, and our Company’s Quality Management System focusing on batch record review, process/aseptic observations, critical site review, critical alarm management, environmental monitoring incursion/excursion response.
• Will support and prepare Set-up Activities for SFQA First Shift (Days).
• Support Operations and the Technical Operations Deviation Management groups with event assignments, classifications, investigations, corrective and preventative actions, reviews and approvals through current Quality Systems (e.g., CLUE and SAP).
• Support and maintain a "Safety First", " Quality Always" environment with participation in Site GEMBAs for Safety and Quality Compliance.
• Escalate and collaborate quality and compliance issues as needed through established site Tiers.
• Leads and Supports the Aseptic Observer Program (AOP) and Batch Record Review (BRR) workstreams for the SFQA Area.
• Makes decisions guided by policies and procedures that impact the team’s ability to meet performance objectives and metrics.  Consults on an as-needed basis with next level manager on more complex decisions.
• Actively sponsor and develop a culture that defines a High-Performing Organization including proactively providing developmental support, coaching and assistance to team members.
• Support compliance to Durham Site policies and procedures that promote Permanent Inspection Readiness (PIR).
• Consults on an as-needed basis with next level manager on more complex decisions.

Minimum Required Education and Experience:

• Bachelor’s degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline with five (5) years in the pharmaceutical industry or highly regulated industry. OR

• Master’s degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline with three (3) years in the pharmaceutical industry or highly regulated industry

Required Experience and Skills:

• Minimum two years in aseptic manufacturing or other clean room environment
• Minimum one year in people management or equivalent direct leadership experience.
• Strong contemporary knowledge of relevant current good manufacturing practices (cGMPs), regulations and current industry trends.
• Effective decision making, problem solving and communication.  Ability to manage multiple priorities.
• Demonstrated ability to work in fast-paced, complex environments and escalate appropriately.
• Schedule: Initial training will begin on Day Shift before transitioning to 2nd Shift

Preferred Experience and Skills:

• GMP quality experience with media, biological drug substance and drug product.
• Strong Background in cGMP document review and approval.
• Strong background in cGMP compliance standards (QMS, EHS, and Site SOPs)
• Independent, self-directed strong skill sets in planning / scheduling, and time management.
• Experience with Quality Risk Management.
• Experience with Deviation Management.
• Experience with Kneat, Veeva Vault, MEDS, SAP, Electronic Batch Records (MES