Talent STEM are partnering with a leading global pharmaceutical manufacturing organisation operating within a highly regulated sterile environment. This business is recognised for its commitment to quality, innovation and operational excellence, delivering critical drug products to patients worldwide.
Due to ongoing investment and growth across their Drug Product Services network, they are seeking an experienced Senior QA Expert to support quality oversight and compliance at their Stein site.
The Opportunity
This is a senior quality position where you will act as a key point of contact for QA activities across manufacturing and project operations.
You will provide expert oversight of GMP compliance, support investigations and drive continuous improvement initiatives, working closely with cross-functional teams to ensure the highest standards of quality within sterile manufacturing.
Key Responsibilities
- Act as the primary Quality point of contact for assigned manufacturing and project activities
- Author, review and approve GMP documentation including SOPs, risk assessments, work instructions and cleaning documentation
- Review and approve quality records such as deviations, CAPAs, change controls and validation documentation using systems such as TrackWise and KNEAT
- Provide QA oversight across manufacturing operations to ensure full cGMP compliance
- Support investigations including root cause analysis, impact assessments and implementation of corrective actions
- Partner with operational teams to support growth projects in line with global and local GMP standards
- Lead or contribute to continuous improvement and lean initiatives to enhance quality systems and efficiency
- Monitor project progress and ensure effective communication of quality-related activities
- Collaborate with external partners and customers to define release strategies in line with regulatory expectations
- Define, manage and report Quality KPIs where required
- Support internal and external audits and regulatory inspections
- Provide guidance and mentorship to team members and deputise for QA leadership when required
About You
We are looking for an experienced QA professional with a strong background in pharmaceutical manufacturing who is confident operating in a fast-paced, regulated environment.
You will likely bring:
- A degree (MSc or PhD) in Chemistry, Biology, Pharmacy or a related discipline
- 5 to 10 years’ experience within Quality Assurance or Quality Control in pharmaceutical manufacturing
- Strong knowledge of cGMP and regulatory compliance within sterile or drug product environments
- Experience working with electronic quality systems such as TrackWise and or KNEAT
- Proven experience supporting investigations, deviations and quality systems
- Strong problem solving, decision making and organisational skills
- A collaborative approach with the ability to engage cross-functional teams
- Fluent English skills, German is advantageous
Why Apply?
This is an opportunity to join a globally recognised pharmaceutical organisation and play a key role in maintaining and enhancing quality standards within sterile manufacturing.
You will work in a collaborative and high-performing environment, contributing directly to product quality, regulatory compliance and continuous improvement across a critical manufacturing site.
For a confidential discussion, please contact Talent STEM directly.
Talent STEM is a specialist recruitment consultancy supporting the scientific, engineering, clinical, chemical, pharmaceutical, FMCG, environmental, biotechnology and medical device sectors