GMP Compliance and Quality Assurance Auditor and SOP Technical Writer.

Job description

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. 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 ProPharma’s CQA program, policies, and strategies in compliance with GxP regulations and industry trends. Essential Functions: 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 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 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 or UK can function as QP / RP / RPi (as applicable) for clients. If applicable, an 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 US FDA, ICH, EMA, MHRA 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 Quality and Compliance 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, or similar college degree, in a scientific discipline as a minimum A graduate degree (MSc / PhD) in a scientific discipline is preferred. As applicable, eligible to be registered as a Qualified Person (QP), Responsible Person (RP) and Responsible Person import (RPi). Experience Requirements: Minimum 5 years relevant experience in quality assurance and regulatory / GxP compliance As applicable, previous registration as a Qualified Person Strong working knowledge of GxP principles including the Code of Federal Regulations (CFRs) and EU GMP / GDP regulations. For Consultant, CQA roles that are primarily focused on auditing, minimum of 1 year experience leading audits (e.g. audit prep, running the audit, writing final report, etc.) and recent auditing experience is required (at least 5 audits performed in the past year as reflected in the candidate’s audit log). #LI-EB3 #CQA #GxP 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. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not. Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***