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Quality Assurance Manager

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Department  :  Quality Assurance

Reporting to the Quality Director, North America, the Quality Assurance Manager provides leadership and direction to drive manufacturing operations and suppliers towards higher quality products and processes in accordance with corporate strategy, cGMP, cGLP and regulatory compliance. Excellent commercial acumen with the ability to collaborate and communicate at various levels and supporting operational excellence. A resilient people leader to change, with the ability to make “best for the business” decisions effectively and readily; with responsibility for quality cost/awareness and budgetary control. This includes developing strategic business plans and the tactical actions and resources necessary to execute them and will be responsible for managing operational budgets including leading continuous improvement initiatives in quality.

KEY DUTIES

Management of Quality Assurance Function

  • Provides leadership in developing and leading quality assurance and improvement initiatives for all company and supplier products and ensures ongoing compliance with local, national, and international standards and legislation.
  • Promotes and advocates quality achievement and performance improvement across the organization by integrating quality control tools into processes (e.g. Continuous Improvement) and supporting new product development.
  • 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; analysing variances; initiating corrective actions.
  • Monitors QA systems and advises SLT and NA Director of Quality on system performance; publishes statistics regarding performance against set goals and makes recommendations.
  • Leads the preparation for Health Authority inspections and audits and provides support to their execution and follow-up. Ensures that corrective and preventive actions (CAPAs) are tracked and implemented as committed and ensures timely remediation of any issues related to CAPAs.
  • Acts as the primary contact with regulatory agencies for all communication for the site.

Lead and Develop

  • Manage the training and professional development of QA employees, ensuring that training needs are identified, and personal development programs are implemented on an annual basis. Conduct performance appraisal with all direct reports on an annual basis.
  • Managing the training and professional development of staff in a harmonious and productive environment. Leads by example and proactively communicates and collaborates with internal staff, colleagues, the union and external stakeholders to drive results.
  • 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.
  • Take full accountability and ownership for all people related matters and all aspects of the employee life cycle from hiring, onboarding, talent management and employee retention. Be the role model of the company values, leading by example and maintaining high levels of employee engagement.

Support Operational Excellence

  • Work closely with other members of Operations group to ensure delivery of key project objectives and timelines
  • Work directly with other key Company departments to ensure compliance and productive working relationships.
  • Manage relationships with Partners and Vendors for Quality related activities, including being key company contact person for such relationships
  • Assist with troubleshooting quality issues at Partner’s or vendor’s site or associated with technology transfer, when required.
  • Integrate, contribute, and/or lead cross-functional project teams as required.  Support projects schedules as required.

Quality Management System

  • Responsible for ensuring that all product quality complaints (vendor and customer complaints) are being adequately investigated, trended, & reported and collaborates with department to ensure full customer satisfaction.
  • Responsible for final product release to customer.
  • Acts as a liaison with customer auditors and ensures corrective actions are completed according to customer specifications.
  • 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. Approves/rejects as required.
  • Change control and document change control systems
  • GMP/GLP Training program
  • Annual product reviews system
  • Other duties as assigned.

Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post.  Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.

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 optimise the health, wellbeing and productivity of the world’s animals.

Bimeda’s global innovation programme sees six state-of-the art R&D centres across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.

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 commercialisation 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.

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