Local Quality Owner Late Stage & Value Optimizer (f/m/d), 80-100% Location: Schaffhausen, Switzerland
Cilag AG in Schaffhausen, Switzerland is part of the Johnson & Johnson Innovative Medicine (J&J IM) Supply Chain organization and is currently recruiting for a role focused on QA oversight of a selected portfolio of established (Combination-) Products manufactured at the J&J IM Schaffhausen site.
We manufacture high quality pharmaceutical drug products (Small and Large Molecules) and active pharmaceutical ingredients (APIs). Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all major global markets. The Schaffhausen facility is a center for launching and accelerating growth in parenterals, supported by an impressive pipeline of new and innovative products.
Position summary The function holder is responsible for the QA oversight of a selected portfolio of established (Combination-) Products, which are manufactured at the J&J IM Schaffhausen site.
Principal responsibilities
Key Contact for internal and external stakeholders (operations, planning, logistics, engineering, regulatory affairs etc.) within cross‑functional teams in terms of Quality and Compliance.
Q&C contributions including Decision making and problem solving and oversight of assigned, established manufacturing lines.
Investigation lead for major non–conformances (deviations) including CAPA alignment with Operations counterparts.
In‑time release of parenteral products (intermediate and finished products).
Proactive risk mitigation.
Review and approval of non‑conformances (deviations) records and change requests.
Review and approval of GMP critical SAP master data (e.g. bill of material, manufacturing instructions etc.).
Review and approval of work instructions and standard operating procedures.
Support of cross‑functional and global projects.
Review of Annual Product Reviews.
Qualifications
A minimum of a Bachelor’s degree, preferably in a technical/scientific field. A Master’s degree or advanced is desirable.
Minimum of 5 years of experience in a GMP regulated Pharma production environment or in a relevant quality or supply chain role.
Strong understanding of parenteral fill/finish manufacturing incl. device assembly and packaging processes.
In‑depth knowledge in GMP standards, policies and procedures.
Knowledge about regulatory guidelines preferred.
Advanced communication skills, verbal and written in both English and German.
We are looking for a dynamic and solution‑oriented individual eager to contribute to our team and drive success in a collaborative, international and fast‑paced environment. If you see yourself in this role, we encourage you to share your application materials with us without hesitation.
Required Skills: Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact‑Based Decision Making, Human‑Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)
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Cilag AG in Schaffhausen, Switzerland is part of the Johnson & Johnson Innovative Medicine (J&J IM) Supply Chain organization and is currently recruiting for a role focused on QA oversight of a selected portfolio of established (Combination-) Products manufactured at the J&J IM Schaffhausen site.
We manufacture high quality pharmaceutical drug products (Small and Large Molecules) and active pharmaceutical ingredients (APIs). Cilag AG is one of the largest pharmaceutical manufacturers in Switzerland supplying all major global markets. The Schaffhausen facility is a center for launching and accelerating growth in parenterals, supported by an impressive pipeline of new and innovative products.
Position summary The function holder is responsible for the QA oversight of a selected portfolio of established (Combination-) Products, which are manufactured at the J&J IM Schaffhausen site.
Principal responsibilities
Key Contact for internal and external stakeholders (operations, planning, logistics, engineering, regulatory affairs etc.) within cross‑functional teams in terms of Quality and Compliance.
Q&C contributions including Decision making and problem solving and oversight of assigned, established manufacturing lines.
Investigation lead for major non–conformances (deviations) including CAPA alignment with Operations counterparts.
In‑time release of parenteral products (intermediate and finished products).
Proactive risk mitigation.
Review and approval of non‑conformances (deviations) records and change requests.
Review and approval of GMP critical SAP master data (e.g. bill of material, manufacturing instructions etc.).
Review and approval of work instructions and standard operating procedures.
Support of cross‑functional and global projects.
Review of Annual Product Reviews.
Qualifications
A minimum of a Bachelor’s degree, preferably in a technical/scientific field. A Master’s degree or advanced is desirable.
Minimum of 5 years of experience in a GMP regulated Pharma production environment or in a relevant quality or supply chain role.
Strong understanding of parenteral fill/finish manufacturing incl. device assembly and packaging processes.
In‑depth knowledge in GMP standards, policies and procedures.
Knowledge about regulatory guidelines preferred.
Advanced communication skills, verbal and written in both English and German.
We are looking for a dynamic and solution‑oriented individual eager to contribute to our team and drive success in a collaborative, international and fast‑paced environment. If you see yourself in this role, we encourage you to share your application materials with us without hesitation.
Required Skills: Business Alignment, Business Savvy, Coaching, Communication, Compliance Management, Continuous Improvement, Fact‑Based Decision Making, Human‑Centered Design, ISO 9001, Issue Escalation, Problem Solving, Quality Control (QC), Quality Management Systems (QMS), Quality Standards, Regulatory Environment, Standard Operating Procedure (SOP)
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Local Quality Owner Arbeitgeber: JOHNSON & JOHNSON
Johnson & Johnson bietet eine herausragende Arbeitsumgebung, die von einer starken Unternehmenskultur geprägt ist, die Innovation und Zusammenarbeit fördert. Als Global Head, IDAR Strategy & Business Operations haben Sie die Möglichkeit, in einem dynamischen Team zu arbeiten, das sich der Entwicklung lebensrettender Medikamente widmet, während Sie gleichzeitig von umfangreichen Weiterbildungs- und Entwicklungsmöglichkeiten profitieren. Die Standorte in Allschwil, Basel und anderen internationalen Büros bieten nicht nur eine attraktive Lebensqualität, sondern auch ein inspirierendes Umfeld, das Vielfalt und Inklusion schätzt.
