Senior Compliance & Quality Assurance Consultant

For the past 25 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.

• Primarily responsible for representing the company as a Subject Matter Expert (SME) in assigned areas of quality assurance and regulatory/GxP. Responsible for providing independent consultation and management of projects within the CQA business practice.

• Support the execution of the strategy for their respective CQA service line. This includes ensuring profitability of projects, and as applicable, the monitoring of performance of current personnel executing assigned projects.

• Keep pace with the regulatory and technological changes int he 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 a SME and identify scope and effort required to successfully address client needs.

• Support marketing efforts by promoting CQA services through presentations and development of social media content and blogs.

• Promote continual improvement regarding customer satisfaction with emphasis on CQA consulting services.

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

• It is anticipated that this position will maintain a percentage of billable work as determined on a yearly basis from the service line budget tiers.

• Other duties as assigned

Required Skills / Abilities

• Strong knowledge of applicable US FDA, ICH, EMA, MHRA regulations and guidance documents.

• High-level expertise in GxP 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 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.)

• Quality orientation and high attention to detail.

• Strong analytical skills.

Education / Experience Requirements

• Bachelor's degree, or similar college degree in a scientific discipline as a minimum.

• Graduate degree (MSc/PhD) in a scientific discipline is preferred

• Minimum 10 years relevant experience in quality assurance and regulatory/GxP compliance.

• Minimum 3 years managing a technology business or business unit or CQA SME lead is preferred.

• Minimum of 3 years recent experience in leading audits (e.g., audit prep, running the audit, writing the final report, etc.) is required. Candidate's Audit Log should reflect at least 5 audits performed per year.

• Strong preference for candidates with experience working in a QC laboratory, preferably in a chemistry/analytical lab.

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