Manager, Quality Assurance

MSD • Millsboro, DE

1d • Hybrid

About The Position

Our Quality Assurance group ensures our products are manufactured, processed, tested, packaged, stored and distributed aligned with our high standards of quality and meet all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers, we create an interdependent global manufacturing network committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe. The Quality Assurance Manager will direct QA activities and provide support and expertise to the Millsboro, DE site. Collaborates with Quality Control, Regulatory Affairs, Manufacturing, EHS (Safety), R&D, BTS (Bio-process Technology Support) and ATS (Analytical Technology Support) to ensure site quality systems, processes and projects meet or exceed regulatory and company standards. Collaborates with site leadership on quality standards and release criteria to ensure that all products are pure, safe, potent and efficacious. Manages team members to include coaching on quality principles, inclusive behaviors, and best practices. Interacts with our Company sites for best practice sharing. The Manager of Quality Assurance at the Millsboro site reports to the Associate Director of Quality. The QA manager will oversee a staff of ~10 employees and is responsible for the execution and oversight of all Quality Assurance activities including but not limited to the following: Prioritizing the schedule of Quality activities in accordance with customer requirements. Performing Quality review, approval, and submission of finished product serials Managing Product Release submission process to USDA CVB. Document Management including Batch Record Review and archiving, SOP Management and review, Test Record review and approval, and Regulatory Communications. Performing GMP walk through inspections of assigned departments to ensure compliance with cGMPs and regulatory requirements. Assistance with external audits may also be required. Direct support and management of Regulatory Authority Inspections. Authoring, reviewing and approving revisions to SOPs, technical documents, including risk assessments and investigation reports. Aiding all areas of the site in drafting and review of significant investigations as needed. Performing Quality reviews and approval of new and updated Procedures and Controlled Job Aids. Quality Risk Management oversight. Assisting with annual review of the Site Master Plan. Other duties as required by management. Actively participates in the Tier process and uses this forum to escalate concerns and best practices.

Requirements

• Associate's degree in a scientific or analytical field, with (8) years’ relevant experience. Candidates with degrees in other fields will be considered if accompanied by significant relevant experience.
• OR Bachelor’s degree in scientific or analytical field, with five (5) years’ relevant experience.
• OR Master’s degree in scientific or analytical field, with three (3) years relevant experience.
• Minimum of Five (5) years of experience in Biological operations, technical services and/or Quality operations with experience understanding the quality function.
• A minimum of one (1) year of experience in a leadership role (manager, supervisor or lead position).
• Knowledge of aseptic processing and sterility assurance
• Proven problem-solving skills
• Analytical Testing
• Aseptic Processing
• Biomanufacturing
• Change Management
• Configuration Management (CM)
• Cross-Functional Teamwork
• Detail-Oriented
• Deviation Investigations
• Document Management
• GMP Compliance
• Health and Safety
• Inspection Systems
• IS Audit
• Management Process
• Occupational Safety and Health
• Packaging Science
• Prioritization
• Process Quality Control
• Quality Assurance (QA)
• Quality Assurance (QA) Standards
• Quality Assurance Processes
• Quality Control Management
• Quality Management Systems (QMS)

Nice To Haves

• Experience in Quality Control or Quality Assurance
• Familiar with USDA 9 CFR regulations.
• Animal Vaccine experience
• Prior project management experience

Responsibilities

• Prioritizing the schedule of Quality activities in accordance with customer requirements.
• Performing Quality review, approval, and submission of finished product serials
• Managing Product Release submission process to USDA CVB.
• Document Management including Batch Record Review and archiving, SOP Management and review, Test Record review and approval, and Regulatory Communications.
• Performing GMP walk through inspections of assigned departments to ensure compliance with cGMPs and regulatory requirements.
• Assistance with external audits may also be required.
• Direct support and management of Regulatory Authority Inspections.
• Authoring, reviewing and approving revisions to SOPs, technical documents, including risk assessments and investigation reports.
• Aiding all areas of the site in drafting and review of significant investigations as needed.
• Performing Quality reviews and approval of new and updated Procedures and Controlled Job Aids.
• Quality Risk Management oversight.
• Assisting with annual review of the Site Master Plan.
• Other duties as required by management.
• Actively participates in the Tier process and uses this forum to escalate concerns and best practices.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Education Level: Associate degree
• Number of Employees: 5,001-10,000 employees