Quality Assurance Consultant - Responsible Person

About ProPharma

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.

Role Overview

The Compliance and Quality Assurance Consultant, QP / RP 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. 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, 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, 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 and regulatory/GxP. They will be responsible for providing consultation and support the management of projects within the CQA business practice.
• Manage and undertake project work on own 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.
• 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. 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.
• It is anticipated that this position will maintain >85% billable project work as determined on a quarterly basis.
• The Consultant, CQA in EU or UK can be assigned the role of “Manager QA for ProPharma MIA License”; who’s role, responsibilities, duties, and training requirements are detailed in the separate QMS supporting the ProPharma MIA License.
• Eligible QP can be assigned the role of “QP for ProPharma MIA License” whose role, responsibilities, duties, and training requirements are detailed in the separate QMS supporting the ProPharma MIA License.
• Other duties as assigned.

Necessary Skills and Abilities:

• Knowledge of applicable EMA regulations and guidance documents.
• Expertise in GxP systems and capable of providing consultation based on previous experience and system knowledge.
• 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.
• 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 write, type, express or exchange ideas; ability to convey information/instructions accurately in English and one other European language preferred (for EU employees).
• 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.

Educational Requirements:

• Bachelor’s degree in a scientific discipline as a minimum
• A graduate degree (MSc/PhD) in a scientific discipline is preferred.
• Eligible to be registered as a Qualified Person (QP) and/or Responsible Person (RP)

Experience Requirements:

• Minimum 5 years relevant experience in quality assurance and regulatory/GxP compliance, and a registered Qualified Person and or Responsible Person
• Strong working knowledge of GxP principles including the Code of Federal Regulations (CFRs) and EU GMP/GDP regulations.

Our Commitment to Diversity, Equity, and Inclusion

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.

ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.