Quality Operations Laboratory Manager

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

General Summary:

The Quality Operations Laboratory Manager leads a team of Environmental Monitoring analysts in routine sampling, testing, start-up and method transfer activities at the Durham site.The successful candidate will report to the Associate Director, Laboratory Operations for microbiological testing and environmental monitoring. Method transfer activities may include qualification of equipment, facility and utilities. Successful maintenance of existing facilities or start-up of new facilities will require candidates to work cross-functionally within our company's Laboratories and organizations. The Laboratory Manager will be responsible for routine Environmental Monitoring, trending, Operational support and potential start-up testing of new or modified facilities and utilities using principles of our company's Production Systems, Lean Laboratories, and GMP requirements.

General Profile:

• •Work cross-functionally with our company's internal sites and global partners to build and operate testing capability within the Quality Laboratory Operations.
• •Collaborate with internal customers and vendors to identify, to ensure successful execution of method transfer or method validation activities.
• •Apply project management concepts and techniques as they relate to laboratory testing start-up, regulatory requirements for method transfer/validation project timelines and budgeting.
• •Build knowledge of the company, processes and internal/external customers.
• •Build and maintain strong relationships with site leadership, stakeholders, and customers.
• •Build relationships to work in a highly functioning diverse team environment.
• •Applies team effectiveness skills, listening and integrating diverse perspectives from across the work group; contributes and adds value to the achievement of team goals.
• •Understand and apply cGMP/GLP, Compendial, and other applicable regulatory requirements toward analytical testing.
• •Capability to function effectively within an automated/electronic laboratory environment.

Bussiness Expertise:

• •Understands the fundamental business drivers for the company; uses this knowledge in own work.
• •Understands and applies regulatory/ compliance requirements relative to their role.
• •Influence, motivate, and energize individuals at all levels in the organization.

Functional Expertise:

The Laboratory Manager will be responsible for activities that support cGMP and regulatory compliance during facility design, construction, start-up method transfer/validation activities and routine product testing to include the following:

• •Author/review technical documents, standard operating procedures, change controls, and investigations for the performance of laboratory methods.
• •Trouble-shoot laboratory process and equipment issues as needed.
• •Sample management.
• •Planning and test method execution to meet established delivery timelines.
• •Provide active support during audits and inspections (regulatory, internal, safety).
• •Assist regulatory groups by providing documentation to support the approval of licensure supplements and new product license registrations.
• •Collaborate with Durham Laboratory Compliance to ensure adherence to regulatory requirements.
• •Influence, motivate, and energize individuals at all levels in the organization.
• •Support our Manufacturing Division Divisional and Quality initiatives.
• •Additional project and routine testing support as required by laboratory testing requirements.
• •Other duties as requested by management to support effective laboratory operations and performance metrics.

Problem Solving:

Identifies and solves a range of problems in both straightforward and undefined situations; analyzes possible solutions and assesses each using standard procedures.

Internal Client/External CustomerFocus:

Responds to standard requests from internal and external customers.

Impact:

• •Errors on the job may cause time delays and impact the work of others in own work group or potentially impact product disposition.
• •Influence and Decision Making:
• •Represents Quality in the laboratory to influence cGMP compliance and ensure product quality.
• •Explains information and persuades others in straightforward and low complexity situations as a subject matter expert.
• •Makes decisions within guidelines and policies that impact own priorities and allocation of time to meet deadlines.
• •Escalates potential cGMP or compliance issues effectively in a timely manner for proper resolution to ensure product quality.

Project Management:

• •Accountable for quality and/or technical contribution to project team or sub-team.
• •Lead project team initiatives to ensure timelines are met and laboratories are prepared for routine product testing.

Resource Management:

Aware of costs and assists in controlling costs related to own work.

Required Qualifications:

• •B.S. or M.S. degree in Biological Sciences with a minimum of 5 years of laboratory experience.
• •Experience with execution and trouble-shooting of microbiological testing.
• •Experience in Environmental Monitoring, including sampling, testing, and reporting.
• •Experience with aseptic handling techniques.
• •Technical writing skills.
• •Previous GMP laboratory experience.

Preferred Qualifications:

• •Leadership experience.
• •Experience in new assay development, validation, and/or technology transfer.
• •Experience authoring technical documents supporting regulatory filings (FDA, EMA, JNDA).
• •Knowledge of CFR, Eudralex, and Compendia testing specific to the pharmaceutical industry.
• •Experience in regulatory agency audits and/or regulatory filings.
• •Experience with Lean Six-sigma and problem solving tools.

Working Relationships:

• •Reports to Associate Director, Laboratory Operations.
• •Represents the laboratory in cross functional project meetings.
• •Interacts with employees within own department.
• •Frequent interaction with employees from other departments and across our company's sites.
• •Interacts with representatives from regulatory agencies.
• •Interacts with external suppliers. #EBRG's #VetJobs

Required Skills:

Analytical Method Transfer, Analytical Method Transfer, Aseptic Handling, cGMP Regulations, Decision Making, Environmental Monitoring, External Manufacturing, GMP Laboratory, Good Lab Practices, Good Manufacturing Practices (GMP), Laboratory Instrumentation, Laboratory Operations, Laboratory Research, Manufacturing Quality Control, Method Development, People Leadership, Pharmaceutical Quality Control (QC), Problem Identification, Process Testing, Product Testing, Professional Integrity, Quality Inspections, Quality Systems Compliance, Regulatory Audits, Regulatory Inspections {+ 6 more}

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 affirmat