Compliance and Quality Assurance Consultant

This is a fully remote position, open to applicants in Sweden, +1 more country.

📋 Description

• Assist in the management of compliance and quality assurance-related initiatives.

• Offer consulting and contractual services to clients on quality and GMP concerns.

• Represent the organization in designated areas of quality assurance and regulatory / GxP matters.

• Oversee and execute client MIA / WDA projects and ProPharma MIA license activities, including QP batch certification, GxP auditing, and QMS development as necessary.

• Track regulatory and technological advancements in the CQA sector and cultivate subject matter expertise.

• Contribute to risk-based and phase-appropriate GxP projects.

• Engage in the sales process and determine the scope and resources required to meet client expectations.

• Assist marketing efforts through social media content creation and blog writing.

• Foster continuous improvement in customer satisfaction regarding CQA consulting services.

• Deliver CQA-specific training to clients and colleagues in other business units.

• Support clients and ProPharma functional teams when GxP issues, deviations, and non-conformances occur.

• Provide consultation on the implementation of CAPA to address deviations and non-conformances.

• Ensure company operations adhere to quality principles.

• Participate in the creation of quality systems through SOP documentation and training.

• Engage employees at all organizational levels to educate them on compliance and quality assurance while promoting continuous improvement.

• Maintain a percentage of billable project work assessed quarterly.

• Serve as QP / RP / RPi for EU or UK clients, as necessary.

• Potentially act as QP for the ProPharma MIA License.

• Carry out other duties as assigned.

⛳️ Requirements

• A minimum of a Bachelor’s degree or equivalent college qualification in a scientific field.

• A graduate degree (MSc / PhD) in a scientific discipline is preferred.

• Eligible for registration as a Qualified Person (QP) and Responsible Person (RP) where applicable.

• At least 5-8 years of relevant experience in quality assurance and regulatory / GxP compliance.

• Previous registration as a Qualified Person is preferred where applicable.

• Strong understanding of GxP principles, including the Code of Federal Regulations (CFRs) and EU GMP / GDP regulations.

• GMP auditing experience is also preferred.

• Proficient in English and Swedish (or another EU language).

• Familiarity with applicable US FDA, ICH, EMA, and MHRA regulations and guidance documents.

• Expertise in GxP systems, capable of offering consultation based on previous experience and system knowledge.

• Ability to gain and retain a client’s trust through effective planning, organization, control, and execution of projects.

• Willingness and capability to travel as needed.

• Competence in managing and executing multiple tasks within compliance, quality assurance, and relevant Quality and Compliance Consulting services.

• Strong quality focus and meticulous attention to detail.

• Excellent analytical skills.

• For roles primarily focused on auditing, recent auditing experience is required: at least 5 audits conducted in the past year as indicated in the candidate’s audit log.

🏝️ Benefits

• Permanent employment opportunity.

• Hybrid working model encouraged for new hires residing within a reasonable commuting distance from a ProPharma office, with in-office work as agreed upon with the manager.

• Equal Opportunity Employer committed to diversity, equity, and inclusion in the workplace.

• A safe and empowering environment where employees can express their authentic selves.

• Applications are personally reviewed by a recruitment team.

• No AI screening tools are utilized in the hiring process.

• Applicants receive feedback regarding the outcome of their application.