Pharmaceutical Quality System (PQS) Specialist

Do you have a passion for ensuring Quality Standards are met? In this new role as Pharmaceutical Quality System (PQS) Specialist you will ensure that products or services provided to our customers meet the required quality standards. We need someone with the ambition to look for ways to improve and promote quality on both a local and global scale.

About the team

The Pharmaceutical Quality System department (PQS) is a team of 10 motivated professionals who manage a variety of QA tasks in relation to quality systems, customers audits and regulatory inspections. You will be part of a very competent team that works with a high level of independence and influence on their daily work. we are driven by our commitment to the patient. As a team, we support each other.

The Pharmaceutical Quality Systems (PQS) department is part of the wider Quality group and sits within the Quality Continuous Improvement department which also includes the Operational Resilience team, the Operational Learning &Development team and two experienced Continuous Improvement Partners. We work very closely together as a unit to ensure we capture the learnings and embed it into the PQS.

Our Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities and technologies to manufacture advanced biologics.

Key Roles and Responsibilities

Your primary driver is to support developing and maintaining a robust Pharmaceutical Quality System (PQS), and coordinate customer audits and regulatory inspection where we demonstrate our strong PQS.

• Ensure adequate quality systems are implemented across the business to meet regulatory and customers’ requirements.
  
  
• Support creation and maintenance of quality assurance policies for all our quality subsystems.
  
  
• Interface with Business Process Owners to implement quality system strategies and plans to facilitate continuous improvements of the PQS.
  
  
• Interface with Regulatory Affairs and Business Process Owners to develop robust compliance processes.
  
  
• In collaboration with Regulatory Affairs, interpret and implement quality assurance standard.
  
  
• Assures ongoing compliance with quality and industry regulatory requirements.
  
  
• Be a key support for audits and inspections at the Hillerød site including follow up on observations, actions, process improvement opportunities and extent of condition.
  
  
• Maintain professional working knowledge of relevant regulations, guidance documents, and standards.
  
  
• Identify best practices within the company, and outside of FDB, and serve as a conduit for best-practice sharing.
  
  
• May periodically be assigned specific projects across the company, which align with the company’s strategic plan.

You will report to the Head of Pharmaceutical Quality Systems.

Qualifications

• Bachelor’s or Master’s degree in Engineering, Science, Operations or Business.
  
  
• Minimum 10 years of experience in regulated industries with at least 3 years in pharmaceuticals or medical device.
  
  
• PQS experience in a regulated industry required.
  
  
• Comfortable being involved in audits and inspections.
  
  
• Good understanding of the continuous improvement and lean principals.
  
  
• Working knowledge of MasterControl or other EDMS preferred.
  
  
• Working knowledge of Trackwise system preferred.
  
  
• Formal lean training and comprehensive knowledge of continuous improvement methodologies and tools (i.e. Lean/Kepner Tregoe) combined with excellent project management skills is an advantage.
  
  
• Embraces the Human and Operational Performance principles.
  
  
• Experience in use of Microsoft Word, Excel, and Powerpoint.
  
  
• Ability to learn and use web development tools

Personal skills

• Detail oriented with the ability to see bigger picture and envision step-change scenarios; outstanding conceptual/process skills.
  
  
• Excellent presentation, coaching & communication skills.
  
  
• Comfortable and capable communicating at all levels of the organization

We truly believe in team success at FUJIFILM Diosynth Biotechnologies and therefore it is important that you balance team and individual responsibilities; Exhibit objectivity and openness to others' views; Give and welcome feedback; Contribute to building a positive team spirit; Put success of team above own interests; Able to build morale and group commitments to goals and objectives; Support everyone's efforts to succeed.

Follow Your Genki to FUJIFILM Diosynth Biotechnologies The work we do at FUJIFILM Diosynth Biotechnologies (FDB) has never been more important—and we are looking for talented candidates to join us. We’re growing our locations, our capabilities, and our teams, and looking for passionate, mission-driven people like you who want to make a real difference in people’s lives. Join FDB and help create the next vaccine, cure, or gene therapy in partnership with some of the most innovative biopharma companies across the globe. Here, you’ll work alongside and learn from some of the most dedicated scientists, engineers, and manufacturers in the industry. We’re proud to cultivate a culture that will fuel your passion, energy, and drive—what FDB calls Genki. Join us and discover a community that thrives on diversity and never scares away from a complex challenge. At FDB, you determine what’s possible.

Your Application

Does this sound interesting? Then we urge you to upload your CV and cover letter as soon as possible, as we will continuously invite relevant candidates for job interviews. The job advertisement will be removed when the right candidate has been identified. Should you have any questions, please feel free to reach out to Gema Varela, Head of Pharmaceutical Quality Systems, at +45 41949540

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

About FUJIFILM Diosynth Biotechnologies

FUJIFILM Diosynth Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, Texas, USA. We use our skills, dedication and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.

Our site in Hillerød, Denmark, brings together expertise, capabilities and technologies to manufacture advanced biologics. The large scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. We commenced 6 billion DKK projects to double our manufacturing capacity and to add fill finish to the site.

We offer the chance to be part of a global workplace where passion, drive and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone no matter their background or gender has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.

We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package.

As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team.

Kilde: Jobnet.dk