Senior Compliance & Quality Assurance Consultant

About the role

Primarily responsible for representing the company as a Subject Matter Expert (SME) in assigned areas of quality assurance and regulatory/GxP.

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 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 a SME and identify scope and effort required to successfully address client needs.

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.

Responsibilities

• Earn and maintain a client's confidence through appropriate planning, organizing, controlling, and directing of a project.
• 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.).
• Manage profitability of projects and monitor performance of current personnel executing assigned projects.
• Develop subject matter expertise to take advantage of regulatory and technological changes in the CQA field.
• Contribute to the implementation and successful execution of risk-based and phase appropriate GxP projects.
• Identify scope and effort required to successfully address client needs during the sales process.
• Promote continual improvement regarding customer satisfaction with emphasis on CQA consulting services.
• Train clients and associates within other business units on CQA specific topics.
• Support 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. Ensure compliance of company operations to quality principles and participate in the development of quality systems through SOP writing and training.

Requirements

• 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.
• 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.

Qualifications

• Quality orientation and high attention to detail.
• Strong analytical skills.

Skills

• 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.).

Benefits

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

Pay

Commensurate with experience.

Schedule

N/A