Manager, Quality Assurance Second Shift

Job description

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. 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), Trackwise and GLIMS. RCA (Root Cause Analysis) with problem-solving experience utilizing MPS / LSS tools, including demonstrated proficiency in MPS 8-Step Problem Solving. Software Proficiency: Microsoft Excel, Work, PowerPoint, Teams. #SWE2026 #EBRG #VetJobs Required Skills: Analytical Problem Solving, Analytical Thinking, cGMP Compliance, Decision Making, Detail-Oriented, Driving Continuous Improvement, Key Performance Indicators (KPI), People Leadership, Quality Auditing, Quality Control Systems, Quality Documentation, Quality Management Standards, Quality Management Systems (QMS), Root Cause Analysis (RCA), Supplier Quality Management Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The primary location for this posting is: USA - North Carolina - Durham (Old Oxford) Where required by law, the compensation range for this role is provided below. The salary range for the primary location of this role is: $96,200.00 - $151,400.00 This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits. Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations