Mgr, Quality

GENERAL SUMMARY:

The Quality Operations Laboratory Manager leads a team of analysts in the startup and method transfer activities to develop BCG and future testing capability at the Durham site. The successful candidate will report to the Associate Director Laboratory Operations to lead startup new laboratories for microbiological testing and environmental monitoring. Method transfer activities will include qualification of equipment facility and utilities. Successful startup of the laboratory will require candidates to work crossfunctionally with existing company Laboratories and organizations. The Laboratory Manager will be responsible for startup testing in new laboratories using principles of our companys Production Systems Lean Laboratories and GMP requirements.

GENERAL PROFILE:

• Work crossfunctionally with internal company 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 startup 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.

BUSINESS 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 startup 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

• Troubleshoot 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 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 CUSTOMER FOCUS:

• 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 subteam.

• 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

QUALIFICATIONS:

• B.S. or M.S. degree in Sciences with a minimum of 5 years of laboratory experience

• Experience with execution and troubleshooting 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:

• 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 Sixsigma and problemsolving tools

PHYSICAL REQUIREMENTS:

• Ability to sit stand and move within workspace for extended periods

• Ability to work standing in a laboratory environment for extended periods

• Ability to perform repetitive tasks including frequent hand to finger manipulations grasping pushing and pulling

• Ability to travel

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 company sites

• Interacts with representatives from regulatory agencies