Director of Quality Control

2 weeks ago


Bridgeton, United States CareerBuilder Full time

Experiencing together a unique human adventure

Animal health is key to the health of the planet. Working at Virbac means taking part in a unique human adventure in which the engagement of each individual contributes to its evolution. Encouraging internal mobility between positions and countries, offering individual development plans and building a partnership based on trust between managers and employees are as many perspectives of motivation for our teams. We also offer them a work environment conducive to exploring new territories and balancing their professional and personal lives. Finally, fostering their engagement to animal health also means listening to them and helping them to acquire new skills, preparing them for the challenges of tomorrow and encouraging them to contribute to an ever more responsible approach to our business.

Director of Quality Control

Virbac Animal Health is seeking a Director of Quality Control to join our Quality Control team. This position leads all aspects of the Quality Control functions for Virbac NA by continuously reviewing quality philosophy, practices and procedures to ensure that all products and related information along with services are compliant with Company and regulatory requirements.

Qualified candidates must possess a BS/MS/PHD in Life Science or Chemistry. A minimum of 15 years experience in a FDA-regulated pharmaceutical environment performing QC functions. They must also have a minimum of 10 years management experience in a GMP Quality Control laboratory.

This exciting position will work in Bridgeton, MO. It comes with an excellent benefits package including generous vacation time, sick time, floating holidays, 401k + match, life, medical, dental, and vision benefits, and more

Virbac was also recently named one of the Great Places to Work

Responsibilities:

Area of responsibility 1: [Quality of Products].

Main activities

Manages stability programs (transportation testing, temperature variation, storage testing and stability).

Instigates and coordinates all initiatives to improve overall quality and customer satisfaction.

Provide expert technical analysis and evaluation of quality control issues impacting CMC projects

Oversee QC method transfers and method validations

Provide QC oversight and approval of cGMP QC documents (change controls, deviations, CAPAs, procedures, validation protocols, etc.)

Maintain stability trending databases and oversight on active programs

Oversee Reference Standard program including establishing and maintaining reference standards, approving

qualification protocols and reports, and coordinating release testing

Interact with suppliers during CMO selection and throughout projects for problem solving. Participate in cGMP audits of contract testing labs and CMOs

Expected results:

Ensure compliance and business deliverables are met, make strategic department and project decisions.

Area of responsibility 2: [Regulatory compliance]

Main activities

Oversee QC regulatory compliance and manage efficiency of operations and continuous improvement activities

Identifies desirable changes in the quality control policy and drives the improvement of the quality system.

Promotes policies, quality standards and procedures, and brings methodological support and training for all functions that may have an impact on the quality of products and services.

Expected results:

To ensure the application of quality policy, compliance with all regulatory expectations and standards requirements

Area of responsibility 3: [HR Management].

Main activities

Determines the appropriate quality control organization (human resource needs and structure) to grow and maintain activities.

Anticipates changes in the quality control functions and defines key long-term skills and competencies.

Ensures employee development, sets objectives for them and makes sure the objectives are met.

Ensures a good working environment for all employees.

Expected results:

To ensure employee growth and retention in the way best suited to support the strategic goals of the department and the company

Area of responsibility 4: [Budget]

Main activities

Ensure compliance and business deliverables are met, make strategic department and project decisions, forecast and manage resource and budget needs.

Expected results:

Manages departments within approved budgets.

Profile

Requirements (Diploma and experience)

BS/MS/ PhD in life science or chemistry.

Minimum of 15 years of experience in a FDA-regulated pharmaceutical environment performing QC functions

Minimum of 10 years management experience in a GMP Quality Control laboratory

Skills

Current knowledge of analytical and validation principles, local and international regulations and regulatory policies.

Skilled in directing and managing people, and communicating with Regulatory agencies, customers, employees at all levels of the organization.

Demonstrated ability to make risk-based assessments requiring a high degree of understanding of the overall site objectives.

Virbac provides numerous career opportunities, thanks to the diversity of its jobs and their international dimension.

Joining Virbac means joining dynamic teams ambitious for success.

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