Compliance and Microbiology Manager

6 months ago

Cambridge, Canada Bimeda Full time

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.

**Summary**:
Reporting to the Associate Director of Quality Affairs, the Compliance and 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.

This position is a contract position for 12 months.

**Responsibilities include but are not limited to**:

- 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
- 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
- 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
- Perform gap/risk analysis between applicable and current regulatory standards; establish and implement a quality plan to bring the company into regulatory compliance
- 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
- 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
- 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
- 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.
- Other duties as assigned.

**Requirements**:
**Essential**:

- Ten years’ relevant experience in a regulated pharmaceutical industry including Quality Assurance, Quality Control, with 5 years in a leadership role
- BSc degree in Microbiology or related field
- 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
- Abi

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