Employment Opportunities:

Director, Quality Assurance

The Director or Senior Director, Quality Assurance is a tactical and leadership position that reports to the Vice President of Clinical and Regulatory Affairs and is responsible for overseeing and operating cGMP and cGCP Quality Systems that meet global regulatory requirements and industry standards.  The position will be located in the new Chicago office and is expected to evolve into a supervisory position as the company advances development and commercialization of its leading compounds.  Thus, the ideal candidate would have management and mentoring experience and would be expected to inspire and motivate, and to serve as a role model for reports and colleagues.

Key Responsibilities:

• Create, demonstrate and maintain high commitment to quality and compliance
• Direct, manage and facilitate the development and maintenance of the Quality System during R&D and Commercialization of products in accordance with FDA and ICH guidelines
• Assure that all quality related activities and functions are current, fully-implemented and in compliance with defined standards, and that company personnel are trained appropriately
• Inform senior management of compliance risks, improvements and current status of Quality System
• Work with internal departments and external CROs and CMOs to assure timely and cGXP compliant disposition of products
• Communicate openly and effectively, working to develop team-based approach and to lead and to motivate compliance activities
• Oversee audit program including, if necessary, CAPA activities
• Interface directly with regulatory agencies and host regulatory inspections
• Provide leadership and guidance on system validations tasks and product release
• Investigate customer complaints regarding quality and make appropriate adjustments
• Assist senior management to formulate and to establish company policies and operating procedures (SOPs)
• Represent senior QA Management on relevant teams and in key meetings
• Ensure that all areas of the company meet or exceed quality assurance standards
• Participate in activities related to potential in-licensing and out-licensing of products
• Build Quality Assurance department and provide overall direction to the development of a Quality System program

Requirements:

• BSc in biological or chemical sciences; advanced degree is preferred
• 5-10 years pharmaceutical industry experience with GMP and GCP activities
• In-depth knowledge and understanding of biopharmaceutical regulations, manufacturing, validation and compliance
• Comprehension, implementation and enhancement of Quality Management Systems
• At least 2 years people and project management experience with strong problem-solving skills
• High proficiency in verbal and presentation skills and attention to detail
• Ability to work independently and as a functional leader and participant in teams
• Experience in the implementation, management and conduct of quality system audits
• Approximately 20% travel within the United States and International

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.