Job Summary
The Principal Consultant provides executive leadership and develops best practices for compliance processes and ensures all aspects of Quality Assurance and Operations are in within applicable regulations.
Essential Duties
Provide global strategic leadership for the quality assurance of GxP (GLP, GCP, GVP, and GRP) processes and functional areas.
Proven record with team leadership, problem-solving, project tracking, budgeting, and facilitation of efficient communication between the client and team.
Effectively monitor and ensure applicable regulatory requirements are considered and appropriately incorporated into all programs, ensuring compliance with appropriate regulations and guidelines.
Develop SOPs and working instructions to ensure high-performing compliance operations and effective review processes.
Collaborate with key internal partners and other key stakeholders to ensure business objectives are met, as well as scientifically accurate and compliant.
Prepare and deliver effective presentations for external and internal audiences.
Utilize GxP expertise to drive compliance across QMS and support strategic initiatives.
Lead the operational execution of GxP processes which may include audits, regulatory intelligence, inspection management, change control, or quality risk management.
Essential Duties and Minimum Requirement
Bachelor’s Degree in Life Science or other related discipline.
Preferred: Advanced Degree
Minimum 15 years pharmaceutical or biotechnology experience.
Minimum 10 years in a quality or compliance related leadership role.
Demonstrated experience developing and/or improving a Quality Management System
Working knowledge of international GXP regulations and directives, including USA (FDA), EU (EMA), UK (MHRA), Japan (PMDA), China and ICH Guidelines.
Quality orientation and high attention to detail.
Ability to think ahead and prepare action plans to achieve results.
Excellent analytical skills and the ability to assess and resolve difficult business situations.
Ability to take initiative, maintain confidentiality, meet deadlines, and work in a team environment.
About the Company
Quality Confidential engages the industry’s best talent to offer customized compliance solutions to clients in the pharmaceutical, biopharmaceutical, and medical device industries. We work with our specialized consultants to provide personalized project planning to ensure client project goals are met. Quality Confidential prioritizes partnering with consultants who are highly skilled, experienced, and passionate about problem-solving.
OUR CULTURAL BELIEFS
Authentic Communication - I speak up to create transparent, thoughtful, and timely dialogue.
Service Excellence - I value every client experience and its impact on results.
Passionate Work Ethic - I hold myself accountable and maintain high standards.
Integrity Over Profit - I act with our clients’ best interests in mind.
Creating Partnership from the Heart - I partner with anyone, anywhere to achieve results.