Job Summary
The Compliance Consultant position is responsible for the independent execution of projects for cGMP compliance and/or quality/regulatory process implementation.
Essential Duties
Assist with the development and/or optimization of client Quality Management Systems.
Author and/or review documents for cGMP compliance.
Keep pace with regulatory guidance updates and advances in the pharmaceutical/medical device/biotech industry.
Recognize and provide quality and regulatory support for deviations/non-conformances/CAPA.
Responsible for helping to ensure compliance of client operations all applicable internal and external policies procedures and industry best practices.
Utilize expertise of quality systems and GMP compliance to support the performance of audits, gap analyses, and risk assessments.
Essential Duties and Minimum Requirement
B.S./B.A. in scientific discipline as a minimum.
Minimum 10 years of quality experience in a related industry.
Understanding of the requirements for compliance and quality assurance consulting services in the pharmaceutical, medical device, and biotech industries.
Ability to interact in a professional and positive manner with clients and co-workers.
Strong editorial skills for the review and approval of GMP documentation, including protocols, reports, SOPs, etc.
Effective written and oral communication skills.
Ability to manage and execute multiple tasks within the compliance, quality assurance, and validation fields.
Strong working knowledge of international cGMP regulations, USP standards, and ICH, FDA, and EMA guidance documents.
Ability to earn and maintain clients' confidence through appropriate planning, organization, and direction of a project.
Ability to think ahead and prepare action plans to achieve results.
Excellent analytical skills and the ability to access 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.