Validation and Qualification Senior Manager

Zoetis

Louvain-la-Neuve, Belgium

Position Summary:

The Validation Manager is a leadership role that consist in supervising and developing a team of qualification and validation specialists/technicians.

The mission is to leverage technical and regulatory expertise in order to drive the validation department to the highest level of quality assurance and compliance.

This key person in the company also needs to bring experience in Sterilization Validation, aseptic process and Media Fill simulation.

The Manager must be a committed team player and collaborator.

Main responsibilities:

Responsible for organizing and directing the Validation staff members that are directly involved in the start-up, commissioning, qualification/validation and revalidation activities for the Louvain-la-Neuve site (R&D, production and laboratories);
Develop and manage a site validation master plan in association with Quality Operations;
Develop, implement and maintain effective validation programs that support current regulatory requirements for development and commercial manufacturing activities;
Support critical process and equipment change controls to ensure that all systems are maintained in a validated state;
Represents validation matters in regulatory settings, responds to observations during inspections and implements corrective measures in response to findings/observations;
Ensures that the departmental budgets is projected and maintained to support annual revalidation and global validation programs;
Provides updates and detailed reports to the Department Head;
Serves as a subject matter expert on validation requirements for Aseptic Processing;
Responsible for maintaining solid working relationships with other support groups (Engineering, QA, Manufacturing, etc.) to ensure projects and scheduled tasks are completed on time to satisfy the site goals;
Develops site strategies for validation and compliance to GMP through master plans, policies, and procedures;
Establishes staffing plans and requirements to appropriately meet site objectives, recruit and maintain staff capable of achieving goals;
Ensures projects are evaluated, planned, and implemented within schedule and budget requirements;
Ensures Self Inspection procedures for area of responsibility are in place and in use;
Maintains knowledge of validation best practices across the biologics and biopharma industry.

Basic Qualifications:

Education and experience:

University degree in appropriate discipline (i.e. pharmacy, biology, microbiology, engineering or other scientific discipline);
8-10 years of validation experience in the pharmaceutical/biotechnology industry. At least 5-10 years management experience.

Technical skills and competencies :

High knowledge and competencies in:
- Sterilization validation;
- computer system validation & data integrity;
- process & cleaning validation;
- the newest trends in qualification.
Practical and effective knowledge of main engineering and pharmaceutical technics (analytical and production process);
Knowledge of GMP principles;
Strong integrity and motivation;
Quality-oriented and rigorous mind with a high level of flexibility;
Ability to manage priorities, to plan and coordinate different activities;
Ability to supervise, train and motivate technicians to meet defined objectives and daily testing schedule;
Pragmatism hands on/capable to take decision independently;
Ability to lead and interact effectively as part of an interdisciplinary team;
From a Stakeholder Management point of view, ability to leverage knowledge and capabilities of internal/external partnership;
Strong organizational and communication skills and a demonstrated ability to work in a culturally diverse, cross-functional workplace;
Strong commitment to product quality, customer service, and continuous improvement;
Demonstrated problem solving skills;
Thorough knowledge of EU GMP cGMP compliance in accordance with FDA regulations established in 21CFR, parts 210, 211 and 600 (cGMP manufacturing guidelines for pharmaceuticals and biologics), including Part 11 (software validation);
Experience with Regulatory agencies and audits with agencies;
Demonstrated good English knowledge (oral and written);
Willingness to Travel: <5%;
Experience in change management/quality culture is an asset.