The primary role of the QC Scientist Manager is to support the QC Section Manager(s) in the efficient operational management of the QC Scientists through interaction and collaboration with the QC Section Management team to ensure the group meets Company objectives. They are accountable for providing appropriate support to ensure the delivery of work meets the relevant regulatory standards (GxP); ensuring quality focus, on time delivery and a continuous improvement environment.
The QC Scientist Manager will interact with the QC Section Management team to represent the operational section needs of BioPharmCMC. They will also represent Labcorp with Internal and External Clients to support new business or continued relationship management. They will support the department in Client and Regulatory inspections.
The role will entail supporting the QC Section Manager to meet dynamic business needs such as managing resource (people, facilities, equipment), and assisting in the development and advancement of scientific knowledge within Operations to maintain up to date capabilities.Essential Job Duties:
These statements are intended to describe the general nature of the job and are not intended to be an exhaustive list of all responsibilities, skills and duties.
The QC Scientist Manager will perform most or all of the following tasks, or demonstrate knowledge of the following areas.
The post holder will have direct responsibility for the following in relation to their direct reports:
- Lead motivate and inspire direct and indirect reportees within section
- Performance management of all reportees incorporating:
- Conducting PMD/objective setting and review meetings in a timely manner in accordance with company deadlines
- Use of third party feedback to monitor performance and set actions as appropriate
- Conducting probationary review meetings for direct reportees
- Responsible for ensuring timely completion of:
- Return to work/absence reviews
- Instigation and management of individual improvement plans
- Training record reviews
- Resolution of day to day issues
- Supporting recruitment activities in the BioPharmCMC Division.
- Responsible for the definition, maintenance, and continuous improvement of metrics including but not limited to throughput/headcount (within section), Quality measures and on time delivery of approved data.
- Support the QC Section Manager in the maintenance of a forecast of workload within the section
- To provide leadership to enable the anticipation and rapid recognition of problems, and decision making to avert or correct.
- The QC Scientist Manager may, where appropriate, provide back up and may act as Snr/ Scientist in the review and approval of key scientific data
- Responsible for presentation of facilities/ capabilities of section to clients/regulatory inspectors.
- Support the QC Section Manager in maintaining operational performance metrics, resources, materials and asset utilization and understand their impact upon financial performance within section.
- Provide updates to PMO, Scientific leads and scheduling groups where required on progress of testing and resolution of priority conflicts.
- Working with operational support functions (e.g. Quality Assurance, Equipment Management, Materials Management), and the Section Manager and other QC Scientist Managers to establish, maintain and improve operational processes within BioPharmCMC
- Ensure appropriate scientific support is provided to the proposal generation process
- Support the interaction with Assay Development and the Science and Innovation team to champion the development and advancement of scientific knowledge and standards within section and promote scientific innovation.
- Support the development and advancement of scientific knowledge and standards across BioPharmCMC and promote scientific innovation.
Regulatory and Business Development Support
- To oversee the responses to issues raised following GxP inspections
- Support the process of addressing regulatory issues with Clients and Regulatory Authorities across BioPharmCMC.
- May review and approve regulatory documentation governing the conduct of activity within section and other members of staff as necessary (e.g. Quality Management System approvals).
- May assist the QC Section Manager to support Business Development activities.
The post holder should typically have:
- Computing skills, including word processing and use of spreadsheets (e.g. Microsoft Office packages and Microsoft Project).
- An understanding of health and safety policies, Company policies and procedures, and an understanding of GxP.
- The post holder should be able to communicate effectively at all levels, with other Covance employees, as well as external clients, suppliers, etc.
Education/Qualifications/Certifications and Licenses
- The post holder should have appropriate academic qualifications, appropriate experience in the relevant field, and appropriate experience within a relevant laboratory environment during which a high level of knowledge in related techniques and assays was gained.
- Good communication skills and knowledge of GxP is required.
- This is a junior managerial position and the incumbent will be mentored in the process of good management and interpersonal skills.
MINIMUM EDUCATION/EXPERIENCE/SKILLS/REQUIRED LICENSES OR CERTIFICATIONS:
- Good presentation and client interface skills are also a requirement.
Labcorp is proud to be an Equal Opportunity Employer:
- PhD in Chemistry/BioChemistry/Molecular Biology/Virology or related science, or equivalent related degree, plus 3 years relevant experience in study and people management is preferred. Experience may be substituted for education.
- Good knowledge of regulations, preferably in a contract laboratory environment.
- Laboratory experience - recognized expert in assigned scientific area.
- Skilled in performing presentations, leading meetings, time management and planning.
- Effective communicator with clients, reports and internal stakeholders.
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.
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