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Quality Manager - Belgium
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Posted on : 08 March 2017
- We provide those who raise and care for animals with solutions that empower them to advance a vision of food and companionship enriching life.
- We understand the powerful role healthy animals play in making lives better.
- As pets increasingly become important parts of our families, so too does the need to help them live longer, healthier, higher-quality lives.
- As the global population grows, so too will the need to meet the demand for safe, affordable food for all.
- Our company has been working to empower our customers—from veterinarians to food producers to all those concerned with animal health—to address these global challenges, and advance a vision of food and companionship enriching life.
- We strive to develop and deliver products safe for consumers, animals and the environment through innovation and a shared vision to enrich the life of people worldwide.
- As the central quality contact for our organization, the Quality Manager advises, decides reports, consults and escalates quality matters relating to our products distributed in Benelux and Nordics, to the appropriate affiliate management, Regional Quality Leader or Corporate management when needed.
- The Quality Manager provides independent quality oversight of GMP service providers and is responsible for ensuring that imported products meet the quality that customers expect.
- Names as Responsible Person for products distributed in Belgium - Responsible for information for medicines for veterinary use as per KB 9 July 1984
- Lead the affiliate management to ensure that all operations of the affiliate comply applicable GxP, other applicable company quality standards and local regulations.
- Effectively partner with affiliate leaders to ensure proactive identification and resolution of issues.
- Demonstrate continuous improvement and minimize risk by a routine self assessment, corrective and preventative actions (CAPA), and use of a Quality Plan
- Accountable for product quality related matters, escalate any local product quality related issue to regional quality leadership and affiliate management and lead / collaborate in any local action to be taken as a result of that (i.e. recall, counterfeit etc.)
- Accountable for the completion & accuracy of operational quality tasks, including but not limited to deviations management, change control management, procedure reviewer and approver and maintenance of the Quality Plan
- Ensure that distribution, product release and warehousing is compliant with company standards and external regulatory requirements (i.e. products returned/reintegration, products recall).
- Ensure that Quality agreements, including self-inspection & audits, are in place covering affiliate processes and GMP service providers.Raise Notifications to Management, if and when requiredHalt, hold or quarantine product status, if and when required
- Monitor, trend, interpret & report on Quality metrics & lead continuous improvement activities, in areas including, but not limited to, quality events; complaints and approvals
- Develop local talent to sustain competitiveness; this includes coaching employees; developing and implementing impactful training plans; managing & evaluating performance against expectations / scorecard. Comply with all company local and global policies including Quality frameworks, Code of Conduct, Corporate Citizenship, anti-discrimination, harassment, and health, safety and environment (HSE) policies.Perform any other duties or serve in such other capacity as may be determined by Company management.
Education and Experience
- Master degree in pharmacy, or veterinary sciences; registered with the Orde der Dierenartsen (vet) or de Orde der Apothekers (pharmacy) and relevant experience to become accredited by the FAGG as a responsible person for distribution of veterinary medicines in Belgium.
- Demonstrated leadership / influencing skills in a cGxP environment; preferably within a Quality role
- Ability to both lead and support; and a track record of business partnering with internal stakeholders
- Effective communications (written/verbal), presentation and facilitation skills
- Interpersonal savvy, with the capacity to build strong relationships at a senior level
- Experienced in leading Regulatory Inspection audits and management of HA responses. Demonstrated analytical & investigational skills
- Effective organizational and planning skills; managing near term priorities & strategic aspirations
Fluent in English (written & verbal)Inventory management knowledge highly regarded.
- Act as Responsible Person for products distributed in Belgium
- Responsible for information for medicines for veterinary use
- Act as back-up Responsible Complaints Person for Benelux and Nordic