Pharmaceutical Quality System (PQS) Senior Associate
FUJIFILM Biotechnologies
Dato: for 10 timer siden
By: Hillerød, Region Hovedstaden
Kontrakttype: Entreprenør
Are you passionate about upholding quality standards in a rapidly evolving industry? Do you have the expertise to drive excellence and innovation in pharmaceutical quality systems?
Then we really hope you would like to be our new colleague!
Your New Role
As a Quality Assurance, Pharmaceutical Quality System (PQS) Senior Associate, you'll ensure that our products and services consistently meet quality standards. You have the ambition to enhance and promote quality on both local and global scales.
Your main responsibility is to lead preparations for customer audits and regulatory inspections, demonstrating our strong PQS. You'll continuously identify best practices, acting as a conduit for sharing them.
You will report to the Head of Pharmaceutical Quality Systems.
Key Responsibilities
A detail-oriented, communicative team player who sees the bigger picture and envisions change. Comfortable leading audit preparations and presenting at all organizational levels, with a knack for coaching.
Your New Team & Department
The Pharmaceutical Quality System department (PQS) consists of 11 motivated professionals who manage QA tasks related to the PQS, maintaining quality documents, handling user administration of applications like Veeva and TrackWise, supporting improvement projects, and hosting audits and inspections.
Join a competent team with high independence and influence on their daily work, driven by a commitment to patients. We value open communication within the team and with stakeholders, while emphasizing psychological safety, trust, and empowerment.
Our international and informal environment maintains a high pace and focus on life balance, fun and engagement.
Your Application
Interested? Please upload your CV and cover letter promptly, as we continually interview candidates and will remove the advertisement once we find the right fit.
FUJIFILM Biotechnologies is a global leader in biologics contract development and manufacturing Organization (CDMO), partnering with innovative biotech and biopharma companies to transform healthcare. With locations in Denmark, the UK, and the USA, we support every stage of our customers’ product lifecycle, from breakthrough cures to life-saving vaccines.
Our success starts with our people — their passion drives progress, innovation, and impact. Join a diverse, inclusive workplace that values collaboration, fosters growth, and empowers future generations. Together, we’re enriching communities, protecting the environment, and reimagining healthcare’s potential.
Shape the future with us
— your drive meets boundless opportunity here https://fujifilmbiotechnologies.fujifilm.com/
FUJIFILM Biotechnologies, Denmark is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability, sexual orientation, gender identify or any other protected class.
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.
Then we really hope you would like to be our new colleague!
Your New Role
As a Quality Assurance, Pharmaceutical Quality System (PQS) Senior Associate, you'll ensure that our products and services consistently meet quality standards. You have the ambition to enhance and promote quality on both local and global scales.
Your main responsibility is to lead preparations for customer audits and regulatory inspections, demonstrating our strong PQS. You'll continuously identify best practices, acting as a conduit for sharing them.
You will report to the Head of Pharmaceutical Quality Systems.
Key Responsibilities
- Lead and host audits and inspections at the Hillerød site, following up on observations and process improvements.
- Ensure effective quality systems are implemented to meet regulatory and customer requirements.
- Create and maintain quality assurance documents for all quality subsystems.
- Collaborate with Business Process Owners (BPOs) to implement quality system strategies that facilitate continuous PQS improvement.
- Work with Regulatory Affairs and BPOs to develop robust compliance processes.
- Ensure ongoing compliance with quality and industry regulatory requirements.
- Maintain professional knowledge of relevant regulations, guidance documents, and standards.
- Occasionally manage projects aligned with the company’s strategic plan.
- Bachelor’s degree in engineering, science, operations, or business within the biopharmaceutical sector.
- Minimum of ten years in regulated industries, with at least five years in pharmaceuticals or medical devices.
- Experience in preparing and hosting customer audits and regulatory inspections.
- Working knowledge of Veeva EDMS and TrackWise preferred.
A detail-oriented, communicative team player who sees the bigger picture and envisions change. Comfortable leading audit preparations and presenting at all organizational levels, with a knack for coaching.
Your New Team & Department
The Pharmaceutical Quality System department (PQS) consists of 11 motivated professionals who manage QA tasks related to the PQS, maintaining quality documents, handling user administration of applications like Veeva and TrackWise, supporting improvement projects, and hosting audits and inspections.
Join a competent team with high independence and influence on their daily work, driven by a commitment to patients. We value open communication within the team and with stakeholders, while emphasizing psychological safety, trust, and empowerment.
Our international and informal environment maintains a high pace and focus on life balance, fun and engagement.
Your Application
Interested? Please upload your CV and cover letter promptly, as we continually interview candidates and will remove the advertisement once we find the right fit.
FUJIFILM Biotechnologies is a global leader in biologics contract development and manufacturing Organization (CDMO), partnering with innovative biotech and biopharma companies to transform healthcare. With locations in Denmark, the UK, and the USA, we support every stage of our customers’ product lifecycle, from breakthrough cures to life-saving vaccines.
Our success starts with our people — their passion drives progress, innovation, and impact. Join a diverse, inclusive workplace that values collaboration, fosters growth, and empowers future generations. Together, we’re enriching communities, protecting the environment, and reimagining healthcare’s potential.
Shape the future with us
— your drive meets boundless opportunity here https://fujifilmbiotechnologies.fujifilm.com/
FUJIFILM Biotechnologies, Denmark is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability, sexual orientation, gender identify or any other protected class.
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.
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