External Quality is an agile organization that excels in quality and risk management, through building links with our internal team members and external partners. This role provides quality assurance support and oversight for external manufacturers involved in Synthetic drug products manufacturing.
Locations (3)
Latina, Lazio, Italy
Belgium
Switzerland
Compensation
The anticipated base pay range for this position is: €49’100.00 - €78’200.00
Responsibilities
Provide quality assurance support and oversight for external Synthetics manufacturing operations, including commercial manufacturing, packaging, testing, release, stability and related supply activities.
Review, coordinate and provide quality concurrence or approval, as applicable, for deviations, non-conformances, investigations, CAPAs, change controls, complaints, product disposition records, manufacturing instructions, specifications, validation documentation, technical studies and quality agreements.
Monitor quality and compliance performance of assigned external manufacturers using quality metrics, risk ratings, audit outcomes, inspection history, supplier performance data and issue trends.
Identify, communicate and escalate quality, compliance or supply risks in a timely manner and support practical, risk-based mitigation and remediation plans.
Support qualification, ongoing monitoring and lifecycle management of external manufacturers and strategic partners in alignment with External Quality processes.
Requirements
Bachelor’s degree or equivalent university degree in Pharmacy, Science, Engineering or a related technical discipline
Nice to have: experience working with external manufacturers
Nice to have: contract manufacturing organizations
External Quality is an agile organization that excels in quality and risk management, through building links with our internal team members and external partners.
Locations (3)
Allschwil, Basel-Country, Switzerland
Beerse, Antwerp, Belgium
Latina, Italy
Responsibilities
Provide quality assurance support and oversight for external Synthetics manufacturing operations, including commercial manufacturing, packaging, testing, release, stability and related supply activities.
Review, coordinate and provide quality concurrence or approval, as applicable, for deviations, non-conformances, investigations, CAPAs, change controls, complaints, product disposition records, manufacturing instructions, specifications, validation documentation, technical studies and quality agreements.
The Associate Director, Commercial Quality Operations provides leadership and oversight of commercial quality activities supporting Galderma's U.S. Prescription (Rx), Over-the-Counter (OTC), and Cosmetics portfolios.
Compensation
The target base salary range for this role is $124,000-$160,000 per year.
Responsibilities
Own the U.S. commercial product disposition and release process
Ensure compliant release of Rx, OTC, and Cosmetics products
Review and approve escalated product disposition decisions
Establish release procedures, controls, and performance metrics
Provide quality leadership during supply interruptions and product quality events
Responsible for carrying out Manufacturing Quality Assurance functions within the plant, including deviation resolution, product impact analysis, CAPA, SOP approval, calibration oversight, quality improvement, and cGMP compliance.
Responsibilities
Implement and maintain the effectiveness of the Quality System
Ensure all quality goals are met and procedures comply with company policies
Investigate plant events and document them in the CAPA system
Perform product impact analyses and place product on QA hold
Maintain liaison with other Quality areas and Plant departments
Requirements
Bachelor's degree in Biology, Chemistry or Engineering
The target base salary range for this role is $124,000-$160,000 per year. This range reflects the anticipated compensation for the role. Where pay falls withing the range may vary based on many factors, including, but not limited to, job responsibilities, skills, experience, education, certifications, location and applicable geographic pay zones, market conditions, internal equity and business considerations. Compensation decisions are made based on an assessment of the candidate’s qualifications and the totality of relevant factors.
Responsibilities
Own the U.S. commercial product disposition and release process
Ensure compliant release of Rx, OTC, and Cosmetics products
Review and approve escalated product disposition decisions
Establish release procedures, controls, and performance metrics
Provide quality leadership during supply interruptions and product quality events
Requirements
Bachelor's Degree in Life Sciences, Pharmacy, Chemistry, Biology, Engineering, or related scientific discipline
Nice to have: advanced degree
Nice to have: experience supporting Rx, OTC, and Cosmetics portfolios
QA Specialist supporting MES in Sterile Manufacturing and Device Assembly and Parenteral Packaging, ensuring compliance with GMP and quality requirements.
Responsibilities
Develop and maintain a thorough understanding of the processes within the Sterile Manufacturing area
Provide quality support for the MES project in Sterile Manufacturing area
Review and approve quality-relevant master data, manufacturing instructions and process changes
Participate in projects to optimise workflows for the review and approval of master data, manufacturing instructions and process changes
Assure compliance with the marketing authorization and Good Manufacturing Practices
Requirements
University degree, scientific orientation (pharmaceutical, chemical or biological sciences/engineering)
Monitor quality and compliance performance of assigned external manufacturers using quality metrics, risk ratings, audit outcomes, inspection history, supplier performance data and issue trends.
Identify, communicate and elevate quality, compliance or supply risks in a timely manner and support practical, risk-based mitigation and remediation plans.
Support qualification, ongoing monitoring and lifecycle management of external manufacturers and strategic partners in alignment with External Quality processes.
Requirements
Bachelor’s degree or equivalent university degree in Pharmacy, Science, Engineering or a related technical discipline
Nice to have: Experience working with external manufacturers
Nice to have: Experience working on cross-functional project teams
Nice to have: Experience with product transfer, new product introduction, parenteral, and/or combination products
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