Quality & Compliance Director

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Website Element Materials Technology

Element has an opportunity in the Health Sciences Division, for a Director, Quality & Compliance whose primary responsibility is to lead all quality activities with oversight of three Health Sciences laboratories in North America.  You will provide direct supervision to the Quality Managers at each facility.  In this role, you will also have a great deal of interaction with clients and regulatory authorities, as well as senior leadership.

Responsibilities

  • Ensure compliance with the regulations and standards related to US FDA, Health Canada cGMP regulations and ICH guidances, US DEA and Compendial testing expectations for pharmaceutical production, validation and testing
  • The Director will have proven ability to establish and maintain strong relationships with customers, regulatory authorities and other industry contacts.  This will enable the incumbent to anticipate changes in the quality/regulatory landscape and adjust processes accordingly.  It is critical that this individual possesses the ability to quickly gain the trust and respect of the team, customers and senior leadership within the Division
  • Establish and drive Quality metrics to ensure that activities are consistent with customer expectations, as well as corporate and divisional quality standards
  • Lead Quality strategic planning and set clear objectives for performance and accountability.
  • Work with Quality Managers to track the execution and facilitate completion of events, such as investigations, deviations and CAPAs
  • Support the creation and maintenance of Policies and
  • Standard Operating Procedures
  • Oversee and administer the Vendor Qualification Program including audit logistics, supporting and conducting quality audits and assessments and maintenance of vendor quality records
  • Participate in compliance / risk mitigation and process improvement initiatives
  • Oversee audits conducted by clients and regulatory authorities, including oversight of audit responses
  • Ensure timely revision of Quality Agreements with suppliers and customers
  • Oversee the Quality training program for the Division
  • Participates and advises on adjustments to the Division
  • Quality procedures and processes, as necessary
  • Identifies gaps in quality and compliance procedures that may pose regulatory issues and devise novel solutions
  • Drive standardization of quality procedures and practices within the Division
  • Mentor, motivate and challenge to drive and develop team members
  • Abide by safe work practices and adhere to general safety policies
  • Up to 30% travel within North America

 

Skills / Qualifications

  • 10-15 years of experience managing a cGMP Quality
  • Organization with clear evidence of building and leading successful teams
  • Bachelor’s degree in science, quality or regulatory affairs required., Advanced degree would be a plus
  • Advanced knowledge of the cGMP requirements and ICH guidance documents
  • Thorough understanding of USP, EP and other compendial procedures
  • Effective organizational and time management skills with the ability to multi-task and prioritize assignments as needed
  • Ability to work independently and effectively with a wide variety of colleagues, both inter- and intra-departmentally
  • Ability to develop effective solutions for complex problems and gain leadership support for improvement initiatives
  • Ability to manage effectively, setting clear expectations, establishing accountability, monitoring progress and outcomes
  • Must embody the highest standards of ethics and integrity

To apply for this job please visit element-ext-us.icims.com.

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