D06 - QLTY ASSURANCE METHODS / QA METHODS MGMT - QUALITY MANAGER

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Job description

Job Description

Job Description: Purpose
This position provides quality oversight for material suppliers and vendors used to manufacture, package and test Client clinical and commercial cell therapy products in accordance with Client policies, standards, procedures and international cGMPs. The incumbent will be responsible for the approval activities related to various suppliers including raw material, consumable, external labs, transportation suppliers, etc. used for the manufacture, package and testing of CAR-T products.

Duties and Responsibilities:

The position holder is responsible and accountable for the tasks given below (non-exhaustive list):
Quality oversight of the activities and services provided by suppliers e.g.,
o Serves as the site single point of QA contact for suppliers for cell therapy program.
o Assists with supplier qualification activities of new and current suppliers in support of Clinical and Commercial Manufacturing activities.
o Initiate and Manage Supplier Quality risk assessments.
o Create / negotiate and maintain Supplier Quality Agreements.
o Work closely with the suppliers and involve SMEs to ensure proper and timely resolution of Deviations, Complaint investigations and CAPAs; ensures properly documented per Client procedures.
o Evaluate and communicate supplier quality related changes, ensuring assessment per Client change control procedures and documented in a timely fashion.
o Measure supplier quality performance, periodically collect and share quality performance metrics. Identify potential trends, working closely with supplier to define possible areas for improvement and associated implementation plan.
o Collect supplier quality documentation necessary to support regulatory submissions.
o Hold or actively participate in joint periodic meetings with stakeholders.
Initiate and assess Change control, complaints, deviations/OOS and CAPA management in electronic system - e.g., support and quality guidance to record owners, follow up until completion, owner role as appropriate, closure in a timely manner.
Partner with stakeholders to assess overall supplier performance, including identifying product-specific quality and compliance risks and develop mitigation plans based on a risk-based approach.
Provide timely support and necessary information to QA colleagues and Quality/Supply Chain Management as required.
Act as representation for Quality Operations as required, escalate critical issues to Management as appropriate.

Skills and Knowledge Requirements:

Thorough knowledge of cGMP in the pharma/Biotech industry as well as FDA, EU, and JP regulatory requirements, ICH guidelines.
Knowledge of cell therapy manufacturing processes and testing is preferred.
Good knowledge of sterile products manufacturing processes and testing. Knowledge of aseptic manufacturing processes
Experience with performing/participating in risk assessment exercises.
Experience in Supplier Quality oversight.
Thorough knowledge of and competence in core quality processes - including change control, deviations/OOS, CAPA management, investigations, APR-PQR.
Excellent investigational and QA problem solving skills e.g.
o Able to interpret problems and effectively prepare surrounding communication in a productive manner to management and the group with clarity, brevity, and accuracy.
o Able to recognize and group technical/scientific attributes and drive science-based decisions in most technical areas and to a deeper level in the specific job function.
o Must have strong authorship and be able to critically review investigations, interpret results, and generate technical conclusions consistent with Quality risk management principles.
Analytical mindset e.g.
o Able to assess vendors quality core processes to ensure compliance with relevant guidelines and procedures; able to identify acceptable mitigation actions.
o Able to recognize quality risks and develop contingency plans.
o Able to assess, establish and implement new quality processes in partnership with assigned vendors.
o Able to recognize patterns in reported data and communicate strategic solutions to stake holders cross-functionally.
Skilled in planning and organizing, building relationships, innovation management and resource allocation.
Ability to make independent and objective decisions and to work under minimal supervision with cross functional teams and partners worldwide.
Team spirit. Action-oriented and customer-focused.
Negotiation and persuasion skills.
Good knowledge of most common office software (Microsoft Office).
Good verbal and written communication skills in English a must.
Additional Job Requirements:
None