Job Description
The Associate Director, Quality Operations reports to the Associate Director, QA Operation Schachen Biologics and supports clinical quality activities at our Werthenstein site. They will have accountability for Good Manufacturing Practice (GMP) compliance, ensuring clinical supply functions operate within GMP requirements and compliant clinical drug substance. Driving and supporting compliance-based programs and results which include support and leading cross functional projects, solving complex problems, current Good Manufacturing Practices (cGMP) quality initiatives, quality system improvements, quality directives, compliance metrics and monitoring, Standard Operating Procedure (SOP) management and site procedures.
Responsibilities
* Responsible for the management, execution and leadership of quality activities to ensure compliance with cGMPs, applicable worldwide regulations and our company’s requirements for supported areas.
* Responsible for providing assessments to senior management as to the compliance status and risk posture of supported area(s) and guidance on alignment of policies and procedures with current regulatory expectations.
* Remain informed of current GMP requirements and industry trends as described in applicable worldwide regulations and industry standards. Provide comments on proposed regulations and communicate impacts to client areas. Maintain a proficient level of knowledge related to specialized areas of technical expertise.
* Ensure departmental SOPs reflect departmental procedures and the current regulations. Responsible for oversight of SOPs in supported areas and ensure periodic updates, as appropriate.
* Manage the review and approval of GMP documentation for applicable regulatory filings, clinical supply, development and technology transfer and facility of equipment qualification. Ensure compliance with regulatory and our company’s requirements.
* Coordinate the preparations for regulatory agency inspections, as applicable. Accompany regulatory agency officials conducting inspections of facilities or operations in supported areas, including GMP Certification inspections and issue formal reports of inspection activities. Facilitate inspections by corporate auditors or external, non-government auditors in supported areas. Lead the drafting of responses to inspectional observations to satisfy our company’s regulatory agency requirements.
* Advise supported areas on the GMP compliance aspects of the design of facilities, selection of equipment (including computerized systems), preparation of departmental SOPs, quality practices, policies and interpretation of applicable worldwide regulations.
* Act as Quality representative for internal or external manufacturing programs. Duties include compliance oversight of program-related activities, batch record review and approval, complex deviation and out-of-specification approval, complex change management approval, etc.
* Efficiently manage all activities within resource constraints while complying with all our company’s policies and regulatory requirements.
* Develop quality system and policy for Development Quality department as needed.
* Represent the Development Quality on project teams or committees establishing GMP or quality standards, policies or expectations within our company.
* Actively participate in GMP audit/inspection program for facilities, systems (including computerized systems) and operations at contractors or licensees, engaged in the processing, testing, or holding of clinical supplies. Evaluate deficiencies and assess impact on compliance status. Report issue as necessary summarizing deficiencies. Work with areas to resolve any audit findings.
* Notify appropriate Quality and support area management of compliance issues and performance trends.
Additional Skills and Competencies Considered a Strong Asset
* Experience and in-depth knowledge of fully integrated, automated and recipe driven operation e.g. DeltaV, SAP, Manufacturing Execution System.
* Experience in drug substance manufacturing.
* Participation and leading Health Authority Inspections.
* Fluent in English and conversational German.
Required Experience and Skills
* Experience in pharmaceutical, biotech or other regulated industry.
* Technical writing experience, i.e. investigations, laboratory reports, standard operating procedures, batch records, or protocols.
* Ability to conduct multiple investigations within established deadlines.
* Demonstrated ability to manage multiple projects and initiatives.
Direct Involvement in the following
* Quality Local Lead for Major Companywide Efficiency Project implementation at Schachen such as automated IT systems (EAM/MES PAS‑X).
* QMS Redesign Topic Team Member for facility and Lab QMS to bring Swiss Medic expectations for assessment during the implementation of new QMS.
* Participation in Due Diligence Project to help with the integration of new assets. Participation in review of external vendor documents, supporting risk mitigation and decision‑making for potential deals.
* Upskilling Less Experienced Staff preserves knowledge and maintains the team’s ability to continue managing complex deviations and change controls.
Preferred Education, Experience and Skills
* A Master’s Degree in Engineering, Sciences or related field and at least five years of experience in the pharmaceutical, biotech or another regulated industry.
* Experience with formal problem‑solving techniques and a hands‑on approach to problem solving, such as Root Cause Analysis or Lean Six Sigma tools.
* cGMP experience in a sterile, vaccine, bulk or finished goods pharmaceutical environment.
* Detailed understanding of Critical Process Parameters, Critical Quality Attributes and general principles of equipment qualification.
Required Skills
* Adaptability
* Audit Management
* Compliance Investigations
* Compliance Programs
* Computer System Validation (CSV)
* Deviation Management
* Global Program Development
* GMP Compliance
* Good Manufacturing Practices (GMP)
* Project Leadership
* Project Risk Assessments
* Quality Assurance Systems
* Quality Management System Improvement
* Quality Oversight
* Quality Risk Management
* Quality Standards
* Quality Systems Compliance
* Regulatory Compliance
* Risk Management and Mitigation
* Risk Mitigation Strategies
* SAP PP (Production Planning)
* Strategic Thinking
* Systematic Problem Solving
* Technical Writing
* Training and Development
The Company
Our Company is a leading biopharmaceutical company employing over 1,000 people in Switzerland at three sites. The company’s headquarters are in Lucerne. At the site in Zurich, the company operates a global innovation and development hub. In addition, we manufacture medicines for global clinical trials and operate a forensic laboratory in Schachen (Canton Lucerne). We conduct around 40 clinical trials annually in Switzerland. The main therapeutic areas include oncology, infectious diseases, cardiovascular and cardiometabolic diseases. We also have a broad portfolio of vaccines for the prevention of diseases in children, adolescents, and adults and we are one of the leading companies in veterinary medicine. Furthermore, we take our responsibility to the local community seriously and have been involved for many years in initiatives such as the «Trendtage Gesundheit Luzern» and the «Alliance Health Competence».
We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community around us.
Our Werthenstein BioPharma site in Schachen is where we conduct cutting‑edge research, develop and analyze new biological agents and supply clinical trial products for global clinical studies. The site is also home to one of our global forensic laboratories where we carefully monitor our products through the supply chain to ensure security and safety for our patients.
Requisition ID: R395470
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