GMP Compliance and Quality Assurance Auditor and SOP Technical Writer

For the past 25 years, Pro Pharma 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. Pro Pharma 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, Pro Pharma 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 Compliance and Quality Assurance Consultant (CQA) 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 / GMP issues, as needed. This position will be assigned to quality assurance and regulatory / GxP compliance projects within the company. The specific facet of GxP project scopes (e.g., GMP, GCP, GLP, 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, etc. The Consultant will also be responsible for supporting the design, implementation, monitoring, maintenance, and promotion of Pro Pharma’s CQA program, policies, and strategies in compliance with GxP regulations and industry trends.

• Represent the company in assigned areas of quality assurance and regulatory / GxP.
• Provide consultation and support the management of projects within the CQA business practice.
• 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.
• Support marketing efforts by promoting CQA services through the development of social media content and blogs.
• Promote continual improvement regarding customer satisfaction with emphasis on CQA consulting services.
• As applicable, provide CQA specific training to clients and associates within other business units.
• Provide support to clients and all functional units of Pro Pharma 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 engage with employees at all levels to educate on compliance and quality assurance to drive continuous improvement.
• It is anticipated that this position will maintain a percentage of billable project work as determined on a quarterly basis.
• For CQA Consultant roles that are primarily focused on auditing, recent auditing experience is required (at least 5 audits performed in the past year as reflected in the candidate’s audit log).
• The CQA Consultant in the EU…