Job Title : QA Contract Manufacturing Senior Manager
We are seeking an experienced Quality Assurance professional to lead our Commercial & External Sites Quality Assurance area.
- Ensure excellence in Quality Assurance (QA) management of Contract Manufacturing Organizations (CMOs) and the associated Quality Management System (QMS).
- Leadership of the management and improvement of QMS for external operations on commercial pharma and biopharma products ensuring that needs of commercial production are met and aligns with applicable regulatory standards.
- Provide technical expertise to solve complex quality issues, support manufacturing, QC & QA processes in CMOs and drive continuous improvement initiatives.
- Plan and execute audits acting as Lead Auditor for GMP audits to CMOs, including Biologics manufacturing sites and related supplies / services.
- Involved and manage QA aspects of transfer projects for Pharmaceutical and Biologics and ensure integration into the existing QMS.
Required Skills and Qualifications :
- University degree in Life Science related field.
- Biotechnology background or additional training in biotechnology highly valuable.
- 8-10+ years related experience in external quality management of pharmaceutical / biopharmaceutical products.
- Deep knowledge and direct expertise on Manufacturing / QC / QA & Change Management of commercial Biologics (Drug Substance & Drug Product) is essential.
- Technical working proficiency in quality systems with strong knowledge of GXP and international Regulatory requirements.
- Oral and written communication skills in English are essential.
- Global business environment knowledge and expertise in dealing and negotiation in complex business situations are essential.
Benefits :
This role offers a unique opportunity to work in a dynamic and innovative environment, where you will have the chance to make a real impact on the company's success.
We offer a range of opportunities for career development and growth, including training and mentorship programs, as well as opportunities for advancement within the company.
What We Offer :
- A competitive salary and benefits package.
- The opportunity to work with a talented and diverse team of professionals.
- A dynamic and innovative work environment.
- Opportunities for career development and growth.