We anticipate this position to open by Q2 2020. Direct Full Time Position
The Manager/Associate Director of Quality assurance will be responsible for supporting and fostering quality assurance (QA) requirements and activities related to cGXP (primarily GMP but also including Good Laboratory Practice, Good Distribution Practice, and Good Clinical Practice) in accordance with ICH and FDA regulations and guidelines. This position will also be responsible for quality and regulatory compliance and assure all systems, processes and their outcomes comply with applicable international and national standards, regulations and guidelines. The primary function of the department is to build, monitor and sustain a robust and effective quality system that delivers reliable, high-quality products that meet all customer and regulatory agency requirements and expectations.
DUTIES AND RESPONSIBILITIES:
- Ensure that products and processes meet company and regulatory requirements.
- Maintain a risk-based quality system to support cGXP activities.
- Provide technical assistance and direction to the other functional groups. Interface with regulatory agencies during routine audits, field complaint investigations, and technical interchanges to present the company's viewpoint.
- Partner and provide support with colleagues in Clinical, Medical, Regulatory, and Research departments to provide guidance on applicable regulations.
- Develop, direct and implement validation programs to establish and maintain a satisfactory level of compliance with regulatory requirements.
- Ensure the efficient use of resources in order to achieve department objectives.
- Requires approximately 25 - 35 % travel, which may include overnight and international travel and professional conferences.
- This job has no current supervisory responsibilities.
- Minimum Bachelor of Science, MS preferred in Quality, Regulatory Affairs, Pharmacy, Chemistry or Biology.
- 8+ years’ experience in pharmaceutical operations.
- Strong understanding of the functional areas of manufacturing, materials management, quality assurance and control, microbiology and laboratory operations in a solid dosage manufacturing environment.
- Must have a demonstrable record of developing, implementing and maintaining quality systems