Employment Opportunities:

Manager, Quality Assurance – BANNOCKBURN location

Reporting to the Director, Quality Assurance, the successful candidate will manage all quality assurance, technical services and document control functions.

Essential Duties:

• Manages all quality assurance, technical services and document control functions.
• Provides direction and influence for the development/implementation of all quality systems and programs.
• Manages the quality audit function and assures the effectiveness of the corrective and preventative action processes within the quality management system.
• Assures that products manufactured conform to the intended product design and specifications.
• Reviews quality assurance studies and best practices to improve the quality of processes and products.
• Oversee the approval or rejection of all components, container/closures, in-process materials, packaging material, labeling, and drug product and the vendor interactions to support these activities.
• Oversee the review of production records, specification and CoA.
• Ensure that contractors, vendors and consultants used in regulated activities are appropriately trained and qualified.
• Assist in the management of Quality Assurance audits for compliance with GCP, GMP and GLP requirements (Internal & External), communicate findings and coordinate corrective and preventative action plans across stakeholder community.
• Manage the review, investigation and follow-up on non-medical complaints
• Proactively promote cross discipline and functional teamwork, and quality culture throughout company.
• Provide quality assurance expertise to company personnel and senior management/executives.
• Perform other duties as assigned or required to perform the duties associated with position.

Skills:

• Superior management, analytical, strategic, decision making, interpersonal and mentoring skills.
• Proven track record of building effective internal and external relationships
• Ability to work effectively with cross-disciplinary teams and with vendors.

Qualifications & Experience:

• Extensive knowledge of quality assurance requirements regarding the development, testing, release, and distribution of marketed and/or investigational drug products in the US, Canada and the EU.
• B.S. in a scientific discipline
• Minimum 2 years in a manager position with drug development and/or commercial stage pharmaceuticals.

To apply for this opportunity, please submit your resume in confidence to hr@cytochroma.com. Please ensure that you quote the job title in your email.

We thank all applicants for their interest; however, only candidates under consideration will be contacted. No phone calls please.