Quality Control Laboratory Manager

The QC Manager is concerned with sampling, specifications and testing as well as the organization, documentation and release procedures which ensure that the necessary and relevant tests are carried out, and that materials are not released for use, nor products released for sale or supply, until their quality has been judged satisfactory. QC manager is not confined to laboratory operations, but must be involved in all decisions which may concern the quality of the product.

The QC Manager is reporting to the COO.

Responsibilities

- Approves or rejects, as he sees fit, starting materials, packaging materials, intermediate, bulk and finished products

- Is responsible for specification form, OOS, certificate of analysis, raw materials/consumables certificate of release, stability protocols and certificates, sampling plans, and all generic QC documents (procedures, validation protocols and reports, transfer protocols and reports, …).

- Establishes, validates and implements all quality control procedures, oversee the control of the reference and/or retention samples of materials and products when applicable, ensures the monitoring of the stability of the products, participates in the investigation of complaints related to the quality of the product, etc.

- Ensures that required validations are performed

- Recruits, leads and develops the QC team

- Ensures that QC personnel’s training is adequate and adapted to the needs.

- Ensure the team works in an efficient manner.

- Ensures that QC laboratories are correctly maintained and operational

- Ensures that Production and QC premises are conformed to GMP requirements for clinical or commercial production.

- Ensures that the QC equipment is purchased, qualified, maintained and calibrated in accordance with the validation master plan.

- Is a key contact in the call list for QC emergencies.

- Manage QC planning and makes sure the team is focused on client expectations.

- Ensures that all necessary testing is carried out and the associated records evaluated;

- Ensures QC GMP compliance and implementation of QMS, product quality and team driven by patient safety

- Ensures documentation be ready on time

- Preserves license to operate and ensures implementations of remarks from any audits

- Prepares and participates to audits/inspections

- Agrees and controls (audit) analytical subcontractors in charge of QC tests in collaboration with QA

- Identifies and leads continuous improvement projects

- Implements and follows-up Key Performance Indicators in collaboration with QA

- Suggests new technologies/tests to implement in order to develop QC activities

- Participates in management reviews of process performance, product quality and of the quality management system and advocating continual improvement

- Participates to project technical evaluation in collaboration with Business team

- Contact and collaboration with subcontractors, research partners, clients

- Contact with products suppliers, device suppliers and technical maintenance teams

- Identify, address and document all deviations and implement corrective actions as appropriate

- Is responsible for QC budget and escalate every budget deviation.

- Maintains opened and effective communication with all other departments

- Vehicles EXO values

Qualifications

·      Team leader

·      quality minded

·      customer oriented.

• Proactive, pragmatic, solution driven mindset, thrustworthy
• Organization skills, multitasking, flexibility and autonomous.
• Maintains open, effective, constructive and positive communication with all the departments

·      At least 5 years experience in a cGMP biopharmaceutical environment, including at least 2 years people management.

·      Minimum 5 years experience in Quality control of a pharmaceutical company

·      Familiar with Operational Excellence principles.

·      Confirmed experience in QC techniques (microbiology and safety testings, PCR, various potency testing, cell characterization testing, raw material testing, etc.)

·      Experience in QC equipment qualification.

·      Experience in cell therapy or quality control of cells from human tissue origin.

• English at least B2