Compliance & Quality Assurance Consultant - Responsible Person/Qualified Person

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 Opportunity

The Compliance and Quality Assurance Consultant position is responsible for supporting the management of compliance and quality assurance related projects and providing consulting and contract services to clients to address quality and regulatory issues, as needed. The specific facet of GxP project scopes (e.g., GMP, GDP etc.) that the individual can be aligned with to support will be dictated by the practical job experience and training reflected in their CV. Typical CQA projects include QMS development, QA oversight, auditing, cell/gene therapies, regulatory agency action response, acting as a Qualified Person/Responsible Person etc. The Consultant will also be responsible for supporting the design, implementation, monitoring, maintenance, and promotion of ProPharma Group’s CQA program, policies, and strategies in compliance with GxP regulations and industry trends.

Essential Functions:

• The Consultant, CQA position is primarily responsible for representing the company in assigned areas of quality assurance. They will be responsible for providing consultation and support the management of projects within the CQA business practice.

• Manage and undertake project work such as auditing, developing Quality Management Systems (QMS) etc.

• As applicable to project assignment and geographic location, manage and undertake project work on client MIA / WDA projects, and PPG MIA license, such as QP batch certification, GxP auditing, developing Quality Management Systems (QMS) etc

• Keep pace with the regulatory and technological changes in the CQA field and develop subject matter expertise to take advantage of those opportunities to increase the company’s effectiveness.

• Be a critical team member who contributes to the implementation and successful execution of risk-based and phase appropriate GxP projects.

• Participate in the sales process as required and identify scope and effort required to successfully address client needs.

• Provide QA specific training to clients and associates within other business units.

• Provide support to clients and all functional units of ProPharma as GxP issues such as deviations and non-conformances arise.

• Provides consultation for the implementation of proper CAPA to resolve deviations and non-conformances. Also, is responsible for ensuring compliance of company operations to quality principles and participation in the development of quality systems through SOP writing and training.

• Directly engages with employees at all levels to educate on compliance and quality assurance to drive continuous improvement.

• Other duties as assigned.

Experience required

• A graduate degree in a scientific/Life Sciences discipline is required (Pharmacy would be highly preferable)

• Minimum 5 years relevant experience in quality assurance and regulatory/GxP compliance

• Any previous experience (or current) as a Qualified Person or Responsible Person would be highly preferred but not essential

• Strong working knowledge of GxP principles and ideally EU GMP/GDP regulations.

• Knowledge of applicable EMA regulations and guidance documents.

• Ability to earn and maintain a client’s confidence through appropriate planning, organizing, controlling, and execution of a project.

• Willingness and ability to travel as required.

• Fluency in English and German both verbally and written

• Ability to manage and execute multiple tasks within the compliance, quality assurance, and relevant Life Science Consulting services (e.g., QMS development, QA oversight, auditing, cell/gene therapies, regulatory agency action response, etc.)