Project Manager Quality
Role Summary:
A leading organisation in the biopharmaceutical sector is seeking a Project Manager Quality to oversee quality-related projects and drive continuous improvements within a dynamic and regulated environment. This role offers an exciting opportunity to contribute to the enhancement of quality systems, compliance processes, and operational efficiencies while collaborating with cross-functional teams.
As a key member of the Quality team, you will work closely with departments including Quality Assurance (QA), Manufacturing, Regulatory Affairs, and Supplier Management to support critical projects and ensure alignment with Good Manufacturing Practices (GMP) and industry regulations.
Key Responsibilities:
Quality Project Leadership & Process Improvement
Lead and support quality-related projects to enhance compliance and operational effectiveness.
Compile and report project-related data, metrics, and key compliance indicators (KCIs).
Analyse and present process-related data to identify improvement opportunities.
Oversee change control processes related to quality projects to ensure regulatory alignment.
Contribute to the enhancement and implementation of quality systems, ensuring continuous improvement.
Cross-Functional Collaboration & Stakeholder Engagement
Partner with internal departments, including QA, Manufacturing, and Regulatory Affairs, to ensure seamless execution of quality initiatives.
Provide support on various topics, including supplier oversight, quality agreements, and system improvements.
Assist in audit and inspection preparation, ensuring regulatory readiness and compliance.
Compliance & Quality Assurance
Ensure all quality-related projects adhere to GMP guidelines, regulatory standards, and internal policies.
Maintain oversight of documentation and quality control processes to support inspection readiness.
Support the organisation in achieving and maintaining high compliance standards within quality operations.
Qualifications & Experience:
Education & Background
Degree in Life Sciences, Biotechnology, Biochemistry, Chemistry, Pharmacy, or a related field.
Experience in project management within a GMP-regulated environment.
Skills & Knowledge
Strong understanding of GMP regulations, including FDA, EU directives, and ICH guidelines.
Familiarity with quality systems, change control, and regulatory compliance frameworks.
Proficiency in project management tools and methodologies.
Strong analytical and problem-solving skills, with a structured and precise approach to work.
Excellent verbal and written communication skills in English and German.
Proficiency in MS Office and relevant quality management software.
Leadership & Personal Attributes
Strong organisational and multitasking abilities.
Self-motivated with a high level of personal responsibility.
Ability to work both independently and within cross-functional teams.
Proactive approach to identifying improvements and implementing solutions.
Strong team spirit and ability to engage with stakeholders at all levels.
What's in it for you?
Permanent, full-time position in a continuously growing organisation.
A modern working environment with state-of-the-art facilities.
Flexible working hours and opportunities for professional development.
Competitive benefits, including 30 days of vacation, subsidised meals, and job ticket or parking options.
Be part of an international team within a dynamic corporate environment.
Engage in meaningful work that impacts patient care and quality standards.
This role presents a fantastic opportunity for a quality-driven professional to make a significant impact in a regulated biopharmaceutical setting.
If you are ready to take the next step in your career, we would love to hear from you!