资深合规及质量保证 (合格人员)顾问 - 永久

Job Title: Senior Compliance & Quality Assurance (Qualified Person) Consultant - Permanent
Job Location: Sweden
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level:
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 opportunity
The Senior Compliance and Quality Assurance (Qualified Person) Consultant will be key in supporting a variety of Life science clients across various phases of development and commericalisation within Pharmaceutical and Biological industry. Within these projects, the successful candidate will be responsible for strategic development; project leadership; acting as the SME and providing key support to a range of clients in QA. This role will allow the successful applicant the chance to work on some of the most fascinating projects the market has to offer with the opportunity to fast-track your development across various therapeutic disciplines. In addition, ProPharma also has the opportunity to offer remote working; a competitive remuneration package and a positive work-life balance.
Essential Functions Include:

• The Senior Consultant Compliance, Quality Assurance Qualified Person (CQA) position is primarily responsible for being a key Subject matter expert in assigned areas of quality assurance and regulatory/GxP.

• They will be responsible for providing Independent consultation with clients and project leadership to a range of challenging and fascinating projects across the CQA space.

• Lead and manage project work on client’s MIA/WDA projects, and PPG MIA license, such as QP batch certification, GxP auditing, developing Quality Management Systems (QMS) etc.

• Ensure the successful execution of key projects and ensure profitability

• Keep pace with the regulatory and technological changes in the CQA field

• Be a critical team member who contributes to the implementation and successful execution of risk-based and phase appropriate GxP projects.

• Act as the SME within the commercial process with clients as required and identify scope and effort required to successfully address client needs.

• Actively promote CQA services within the industry across various platforms

• 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.

• Actively perform the function as Qualified or Responsible Perrson (as applicable) for clients.

• Other duties as assigned

Experience required

• Ideally educated to at least a BSc level in Pharmacy or another appropriate discipline

• Must hold 10 years or more experience within Quality Assurance within GXP settings

• 2-3 years or more experience working as a Qualified Person

• Ideally skilled in development and marketed products

• Thorough understanding of the Regulatory landscape within the industry (US FDA, ICH, EMA, MHRA)

• Fluency in English & ideally one other EU language

• Demonstrated project management skills with the ability to prioritise workload and meet deadlines.

• Excellent collaboration and stakeholder skills

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.***

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Originally posted on Himalayas