Senior Consultant, Compliance (GMP, QMS)

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

The Senior Compliance Consultant is responsible for independently managing compliance and audit related projects and providing consulting and contract services to clients to address issues as needed. This position will be a subject matter lead for assigned areas of QA, regulatory and GMP compliance projects.

Essential Functions

• Primary responsible for representing the company as a subject matter expert (SME) in assigned areas of QA and GMP regulatory and compliance.
• Keep up with regulatory and technological changes in the QA and GMP compliance field.
• Act as a critical team member who contributes to the implementation and successful execution of risk-based and phase appropriate GMP projects.
• Participate in the business development process as a subject matter expert (SME) and identify scope and effort required to successfully address client needs.
• Support marketing efforts by promoting QA and GMP services through presentations and development of social media content and blogs.
• Promote continual improvement regarding customer satisfaction.

Necessary Skills and Abilities

• Strong knowledge of applicable US FDA, ICH, EMA, MHRA regulations and guidance documents.
• High-level expertise in GMP systems and capable of providing independent consultation based on previous experience and system knowledge.
• Ability to earn and maintain a client's confidence through appropriate planning, organizing, controlling, and directing of a project.
• Willingness and ability to travel as required.
• Ability to interact in a professional and positive manner with clients and co-workers through strong interpersonal and communication skills.
• Effective written and oral communication skills; ability write, type, express and exchange ideas; ability to convey information/instructions accurately in the English language.

Educational Requirements

• Bachelor's degree, or similar college degree, in a scientific discipline.
• A graduate degree (MSc/PhD) in a scientific discipline is preferred.

Experience Requirements

• Minimum 10 years relevant experience in quality assurance and regulatory GxP compliance.
• Minimum 3 years managing a technology business or business unit or CQA or GMP SME lead is preferred.