Compliance & Quality Assurance Consultant - Permanent role

ProPharma; Stockholms kommun; Hybrid; SEK 120.000 - 180.000; Vollzeit

Zusammenfassung

ProPharma is seeking a Compliance and Quality Assurance Consultant to support QA and regulatory/GxP projects. The role includes QMS development, audits, and CAPA implementation across client sites, with travel as needed.

The ideal candidate holds a science degree with 5–8 years in QA/GxP and strong knowledge of CFRs, EU GMP, and ICH guidance. Fluency in English and Swedish is required; SWE eligibility preferred.

Qualifikationen

• Bachelor’s degree in a scientific discipline or equivalent.
• MSc/PhD in a scientific field preferred.
• 5–8 years QA and regulatory/GxP experience.
• Qualified Person registration preferred but not essential; eligible in Sweden preferred.
• Fluent in English and Swedish; strong regulatory knowledge (US FDA, ICH, EMA, MHRA).

Aufgaben

• Represent the company in quality assurance and regulatory/GxP matters.
• Consult on projects and support management of CQA initiatives.
• Oversee QA activities on MIA/WDA projects and LTS operations.
• Develop and improve QMS, SOPs, and CAPA processes.
• Travel as required and contribute to client communications.

Kenntnisse

Quality Assurance

Regulatory/GxP

QA auditing

QMS development

CAPA implementation

Risk-based project management

English and Swedish

Travel readiness

Ausbildung

Bachelor’s degree in a scientific discipline

MSc/PhD preferred

5–8 years QA/GxP experience

Qualified Person registration preferred (not essential)

Tools

CFRs & EU GMP/GDP knowledge

Jobbeschreibung

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 /GMP issues, as needed. Key projects in the role can include QMS development, QA oversight, auditing, cell / gene therapies, regulatory agency action response, acting as Qualified/Responsible Person once fully trained/approved etc.

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.
• Other duties as assigned.

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.
• Minimum 5-8 years relevant experience in quality assurance and regulatory / GxP compliance
• As applicable, previous registration as a Qualified Person would be preferred but not essential (Eligibleity to be one though in Sweden is highly preferred)
• Working knowledge of GxP principles including the Code of Federal Regulations (CFRs) and EU GMP / GDP regulations.
• Fluent in English and Swedish (or another EU language)
• 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.
• Quality orientation and high attention to detail.
• Strong analytical skills.

Additional information

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.

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.