Head of Quality Assurance - Pharma Solutions

1w1 week ago

KLK Kolb

CH · Full-time · CHF 160,000 – CHF 220,000

About this role

Lead the Quality Assurance department for pharmaceutical excipients at KLK Kolb, ensuring compliance with ISO9001:2015, EXCiPACT, and IPEC-PQG GMP Guide within the group's quality management system. Develop and enforce QA policies and procedures to maintain high standards across operations. Collaborate with departments like Operations and R&D for continuous product quality improvement.

Oversee daily QA processes including material intake, analysis, release, rejection, storage, and usage. Conduct regular cross-audits within KLK Oleo Europe to identify compliance gaps and improvement areas. Prepare and lead customer and supplier audits aligned with industry standards and partner agreements.

Manage the QA team through leadership, mentoring, and development while identifying and mitigating quality-related risks. Resolve deviations, complaints, and issues promptly in collaboration with involved departments. Maintain precise documentation of all QA activities for pharmaceutical solutions.

Develop and deliver GMP training for pharmaceutical excipients to all employees, ensuring up-to-date knowledge. Work closely with Manufacturing, R&D, Product Management, Regulatory Affairs, and Supply Chain teams. Prepare documentation for Drug Master Files and CEP submissions with regulators like FDA, EMA, and CFDA.

Join a growing international company offering a challenging role in Hedingen, Switzerland, within a professional, open, and creative environment. Benefit from personal and professional development opportunities alongside attractive employment conditions.

Requirements

University degree (FH/University/ETH) in a natural science discipline (Pharmaceutical Sciences, Biotechnology, Chemistry, etc.); higher degree preferred
At least 5 years experience in quality assurance in the pharmaceutical industry, preferably with excipient guidelines (EXCiPACT, IPEC, ICH) and basics of GMP, GDP, GWP
In-depth knowledge of regulatory requirements and industry standards
Proven track record in leading and developing high-performing teams
Excellent communication and interpersonal skills
Strong analytical skills and problem-solving abilities
Fluent in English and German; additional languages advantageous
Experience with quality management systems, tools, and project management

Responsibilities

Develop, update, and enforce quality assurance policies and procedures to ensure compliance with ISO9001:2015, EXCiPACT, and IPEC-PQG GMP Guide
Ensure all processes meet relevant industry standards for excipients and drive continuous improvement in product quality and operational efficiency with Operations and R&D
Lead, mentor, and develop the Quality Assurance team
Oversee QA processes including material intake, analysis, release, rejection, storage, and usage
Conduct regular cross-audits within KLK Oleo Europe to verify compliance and identify improvement areas
Prepare and lead customer and supplier audits in line with industry standards and partner quality agreements
Identify and manage quality-related risks, developing mitigation strategies as needed
Ensure timely resolution of quality issues like specification deviations and customer complaints for pharmaceutical excipients

Benefits

Challenging, versatile, and responsible role in a strongly growing international company
Professional, established company with an open, international, and creative work environment
Personal and professional development opportunities
Attractive employment conditions