Quality & Regulatory Affairs Manager

About the job

Mission of the job
Guarantee the quality within the entire flow, from raw material to package, with the aim of continuously attaining optimal quality. Develop and implement internal regulations, guidelines, procedures, etc. with the aim of ensuring that the organization complies with the applicable and current legislation (on national/local level).

Key Responsibility Areas
• Guarantee the quality within the entire flow, from raw material to product, with the aim of continuously attaining optimal quality.
• Maintain the policy lines within the context of the entire quality system and ensure that the entire company adheres to the policy with the aim of being capable of providing optimal quality assurance and to guarantee quality.
• Prepare, lead and follow audits with the aim of effecting ongoing improvement to quality and processes.
• Manage, organize and schedule all quality operations within the organization with the aim of meeting the prescribed quality standards.
• Maintain, update and implement processes with the aim of receiving (national/local) approval for products and services.
• Verify that all firm and regulatory policies and procedures have been documented, implemented and communicated with the aim of making sure every employee knows the applicable procedures and works accordingly.
• Maintain good contacts with authorities with the aim of anticipating on changes or new developments and trends within the sector.
• Stay well-informed about the evolutions and developments, keep his/her knowledge up-to-date within the context of the amendments to regulations with the aim of strengthening his/her credibility by offering a service that is continuously based on updated knowledge.
• Act as a contact for local authorities as regards quality with the aim of creating constructive and honest communication with the various partners
• File appropriate compliance reports with regulatory agencies with the aim of working following applicable regulation.
• Maintain compliance and timely registration for licensing and products associated with the business.
• Identify compliance issues that require follow-up and conduct internal investigation of compliance issues with the aim of continuously looking for process improvements and ruling out non-compliance issues.
• Conduct or direct periodic internal reviews or audits with the aim of ensuring that compliance procedures are followed.

Set yourself apart

You must possess the following qualifications, background and abilities:
• Thorough cGMP experience required
• Business related degree strongly preferred
• Minimum of three years’ experience in quality and/or regulatory management
• Strong background in leadership
• ERP experience required; NAV preferred
• Advanced Excel skills preferred
• Master Control experience preferred
• Strong team player with the ability to work in an independent and productive manner
• Ability to research issues and arrive at logical well-documented analysis and conclusions
• Effective verbal and written communicator

What’s on offer?

B&B Pharmaceuticals is a well-established locally operated small business pharmaceutical wholesaler in the dynamic and constantly growing compounding pharmaceutical industry. We have an open and informal culture where individuals work together in a small office environment. We are looking for experienced and motivated hard working candidates who possess the ability to work independently. B&B Pharmaceuticals is part of a global organization with unique opportunities to grow your skill level and experience. This job opportunity includes a competitive salary, comprehensive benefits including generous paid time off, matched 401k contributions, and performance benefits.
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