Job Description

A brilliant opportunity exists for an outstanding individual capable of fitting into this very rewarding Biological and Environmental Quality Manager role. Our client, a leading medical device company, is looking to hire someone who can bring added value to the team. If you’re dedicated, energetic and detail-oriented, this could be the perfect role for you. Responsibilities include:

1) Manage the operations of the laboratories

2) Act as the Biological Quality and Environmental Quality SME for the site and provide technical knowledge and leadership for sterilization processes in conjunction with support in the resolution of plant challenges, method development and project work

3) Establish and manage testing schedules for the timely release of products and materials in alignment with the business goals and priorities

4) Provide oversight and technical knowledge to ensure the pharmaceutical site cleaning and disinfection program is adequate to ensure control of the cleanroom environment to applicable company, regulatory and statutory requirements

5) Provide oversight and technical knowledge to ensure adequate facilities, instruments, trained personnel and approved procedures for testing of starting materials, bulk intermediate products and finished products

6) Provide oversight and technical knowledge to effectively manage and monitor the environmental quality processes and practices at the site to an applicable company, regulatory and statutory requirements

7) Act as the site Biological Quality and Environmental Quality SME for internal and external stakeholders, regulatory inspections and any other business requirements

8) Establish and maintain certification procedures for test methods and for testing personnel

9) Maintain adequate numbers of qualified personnel to perform and supervise all activities

10) Review, evaluate and provide approval for standard operating procedures, change controls, validation documents, CAPA and laboratory investigations and other documents, as applicable

11) Provide oversight and input to changes that may impact the microbial and particulate control of the cleanroom environment

12) Establish and maintain budgets and expenditures for areas of responsibility

13) Maintain compliance with procedures, testing and data integrity practices

14) Manage and direct the team in alignment with the business goals and directives

15) Hire, train, develop and evaluate exempt and non-exempt personnel

16) Provide oversight and technical knowledge in developing solutions to environmental, particulate, microbial and sterilization challenges for the site and the Biological and Environmental Quality laboratories

17) Provide oversight and technical knowledge to ensure proper microbiological monitoring of plant utility systems

Critical Requirements

1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field

2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)

3) Recent experience in the medical device industry is strongly preferred

4) Preference will be given to candidates with recent experience in quality management

If you are qualified and this seems like just the right opportunity to take your career to the next level, please apply – we want to hear from you!

Compensation and Other Details

Base Salary: Highly competitive package, commensurate with experience