Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimize the health, wellbeing and productivity of the world’s animals. Bimeda’s nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids. Globally, the company focuses on the development, manufacture and commercialization of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.
Reporting to the Associate Director of Quality Affairs, the Microbiology Manager directs and manages the Microbiology laboratory to ensure testing provides the highest quality analytical support for manufacturing. This position also provides manages quality compliance, works with the Operations team to ensure sterility assurance and best aseptic practices and controls for aseptic filling process. This position will also establish performance standards, procedures, and audit controls in order to meet business requirements as well as identify and implement process improvements to increase the efficiency, effectiveness and quality of company operations. This position manages the performance of 3 direct reports; Microbiology Supervisor, Quality Assurance Compliance Supervisor and QA Lead Investigator.
What you’ll do
- Directs and prioritizes the Microbiology laboratory to provide timely and accurate testing of raw materials, in-process and finished goods, and stability program and facility environmental monitoring while ensuring compliance with protocols, cGMP and safety regulations
- Evaluates and decides upon correction actions to be taken in response to excursions in controlled environmental conditions to which products are exposed so that product sterility assurance is maintained
- Provides leadership and subject matter expertise for maintenance and best practises with respect to sterility assurance and aseptic manufacturing practise and control
- Ensures safety of staff through training, policies, procedures and support of the JHSC meetings, inspections and initiatives
- Monitors department and company quality systems and advises management on team performance. Publishes metrics regarding performance against set goals and makes recommendations
- Accomplishes financial objectives by forecasting requirements; preparing an annual budget; scheduling expenditures; analyzing variances; initiating corrective actions
- Achieves results through direct reports by communicating job expectations & company vision; establishing individual goals in line with corporate/departmental objectives, coaching, reviewing performance results; holding accountable; providing training and skill development opportunities for growth and improved performance
- Participates in preparing for and hosting facility audits by customers, FDA and Health Canada including responding to corrective actions and /or observations as required. Ensures that corrective and preventive actions (CAPAs) are tracked and implemented as committed and ensures timely remediation of any issues related to CAPAs
- Ensure the department is adequately equipped with up-to-date instrumentation and equipment that is properly calibrated and serviced. Maintains knowledge of state-of-the-art technologies and instrumentation and implements or acquires these as needed through site CapEx procedures.
- Provides leadership in developing and directing quality assurance and improvement initiatives for all company and supplier products and ensures ongoing compliance with local, national, and international standards and legislation.
- Leads and participates as required in the investigations regarding batch discrepancies, non-conformances, and out-of-specification events to evaluate impact on product quality and ensure corrective action and non-recurrence
- Perform gap/risk analysis between applicable and current regulatory standards; establish and implement a quality plan to bring the company into regulatory compliance
- Other duties as assigned.
- Ten years’ relevant experience in a regulated pharmaceutical industry including Microbiology, with 5 years in a leadership role
- BSc degree in Microbiology
- Knowledge of Microbiology, environmental monitoring, implementing and maintaining a sterility assurance program for aseptic processes, cGMP, Quality Systems, manufacturing and packaging processes.
- Collaborative leader that can drive change
- Persuasive, motivational, persistent
- Effective at working in a fast- paced environment, specifically in a leadership capacity
- Strong verbal, written and presentation skills
- Ability to interact effectively with all levels of the organization.
- Must be able to manage competing priorities
- Must possess strong verbal and written communication skills in English
Core Behaviours, Skills & Abilities:
COGNITIVE FLEXIBILITY – Is the ability to switch from one behavior to another depending on requirements, and reflect on several options to solve problems quickly
COMPLEXITY/STRESS MANAGEMENT /TIME MANAGEMENT-The ability to keep functioning effectively when under pressure and maintain self-control in the face of hostility or provocation. Cuts through complexity to focus on core issues; ability to manage time smartly; manages resources soundly
LEADERSHIP – is the ability of an individual to influence or inspire followers or other members of the organization; to enhance others’ commitment to their work and to a high -performance culture. Provide motivational support, and the ability to develop and communicate goals in support of the business mission. Provides direction with purpose and alignment to Company vision and values.
DELEGATION – is the assignment of authority to another person to carry out specific activities. It is the process of distributing and entrusting work to another person. It is not only giving the responsibility to do the work but the authority to do the work. It is one of the core concepts of management leadership. The ability to convey confidence in employee’s ability to be successful
INTEGRITY/PERSONAL CREDIBILITY – Demonstrated ability and concern that one be perceived as responsible, reliable and trustworthy.
What We Offer:
- Competitive Salary
- Paid Holidays
- Competitive Vacation Policy
- Paid Sick Days
- Medical, Dental, Vision Benefits
- Defined Contribution Pension plan with employer matching
- Employee Assistance Program
At Bimeda we are committed to fostering an inclusive, barrier-free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs.
The job posting is available in an accessible format upon request by contacting the Human Resources Manager.