T
Quality Senior Professional
Job Description
About The Company
Lonza is a leading global provider of integrated healthcare solutions, specializing in the development and manufacturing of pharmaceuticals, biopharmaceuticals, and specialty ingredients. With over 30 sites across five continents, Lonza's diverse and innovative teams work collaboratively to deliver high-quality products that improve lives worldwide. Our commitment to excellence, integrity, and innovation drives us to be at the forefront of the life sciences industry, supporting customers from early-stage research to commercial manufacturing. We foster a culture that values diversity, inclusion, and continuous improvement, ensuring our employees are empowered to make a meaningful impact in the healthcare sector.
About The Role
The Quality Senior Professional, Customer Compliance & QAAs at Lonza is a pivotal role responsible for ensuring that quality agreements (QAAs) and related processes adhere to regulatory, contractual, and organizational standards. This position involves direct engagement in quality negotiations with global customers, facilitating alignment between internal stakeholders and external clients. Operating at a global support level, the role requires a comprehensive understanding of quality standards, regulatory requirements, and contractual obligations, with site-specific negotiations managed locally. The incumbent will play a key role in maintaining compliance, driving continuous improvement initiatives, and supporting audits and inspections, thereby ensuring the integrity and quality of Lonza's products and services.
Qualifications
The ideal candidate will possess a bachelor's degree in life sciences, quality management, or a related field. A minimum of 5 years of experience in quality assurance, compliance, or a similar role within the pharmaceutical or biotech industry is required. Strong knowledge of GMP regulations, quality systems, and contractual negotiations is essential. Excellent communication and negotiation skills, along with the ability to interpret complex regulatory requirements, are crucial for success. Proficiency in English, both spoken and written, is mandatory. Candidates should demonstrate strong analytical skills, problem-solving abilities, and the capacity to manage multiple stakeholders effectively. Experience with digital tools such as TrackWise or other quality management systems is preferred.
Responsibilities
At Lonza, we offer a dynamic and inclusive work environment that encourages growth and development. Our employees enjoy a comprehensive benefits package tailored to role and location, including competitive compensation, health and wellness programs, and opportunities for professional advancement. We promote work-life balance through flexible working arrangements and support ongoing learning through training and development initiatives. Additionally, our global presence provides employees with opportunities for international exposure and career progression. We are committed to fostering a workplace where innovation, collaboration, and integrity thrive, ensuring our team members feel valued and empowered.
Equal Opportunity
Lonza is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based on race, religion, gender, sexual orientation, age, disability, or any other characteristic protected by applicable law. We believe that a diverse workforce enhances our ability to innovate and succeed, and we are dedicated to providing equal employment opportunities to all qualified candidates.
Lonza is a leading global provider of integrated healthcare solutions, specializing in the development and manufacturing of pharmaceuticals, biopharmaceuticals, and specialty ingredients. With over 30 sites across five continents, Lonza's diverse and innovative teams work collaboratively to deliver high-quality products that improve lives worldwide. Our commitment to excellence, integrity, and innovation drives us to be at the forefront of the life sciences industry, supporting customers from early-stage research to commercial manufacturing. We foster a culture that values diversity, inclusion, and continuous improvement, ensuring our employees are empowered to make a meaningful impact in the healthcare sector.
About The Role
The Quality Senior Professional, Customer Compliance & QAAs at Lonza is a pivotal role responsible for ensuring that quality agreements (QAAs) and related processes adhere to regulatory, contractual, and organizational standards. This position involves direct engagement in quality negotiations with global customers, facilitating alignment between internal stakeholders and external clients. Operating at a global support level, the role requires a comprehensive understanding of quality standards, regulatory requirements, and contractual obligations, with site-specific negotiations managed locally. The incumbent will play a key role in maintaining compliance, driving continuous improvement initiatives, and supporting audits and inspections, thereby ensuring the integrity and quality of Lonza's products and services.
Qualifications
The ideal candidate will possess a bachelor's degree in life sciences, quality management, or a related field. A minimum of 5 years of experience in quality assurance, compliance, or a similar role within the pharmaceutical or biotech industry is required. Strong knowledge of GMP regulations, quality systems, and contractual negotiations is essential. Excellent communication and negotiation skills, along with the ability to interpret complex regulatory requirements, are crucial for success. Proficiency in English, both spoken and written, is mandatory. Candidates should demonstrate strong analytical skills, problem-solving abilities, and the capacity to manage multiple stakeholders effectively. Experience with digital tools such as TrackWise or other quality management systems is preferred.
Responsibilities
- Support and execute timely negotiations with global customers to define, align, and finalize Customer QAAs for Lonza, ensuring compliance with all regulatory and contractual requirements.
- Maintain and update quality standards and procedures to ensure adherence to GMP and other relevant regulations.
- Verify that customer QAAs meet the minimum requirements established by Lonza and facilitate their implementation across relevant departments.
- Serve as the primary point of contact for internal stakeholders regarding QAA-related matters, providing guidance and support.
- Coordinate with cross-functional teams including Legal, Quality, Operations, and Commercial to ensure consistency during the implementation of QAAs and related processes.
- Manage the preparation, review, and periodic updates of QAAs, including the withdrawal process when necessary.
- Contribute to continuous improvement initiatives by analyzing workflows, proposing process optimizations, and supporting the implementation of digital tools and automation solutions.
- Ensure alignment between internal processes and commitments outlined in QAAs, driving harmonization across global sites.
- Collaborate with global quality teams and other sites to drive process improvements, increase efficiency, and promote best practices.
- Provide expert guidance on compliance topics, sharing knowledge across the organization to enhance awareness and adherence.
- Manage TrackWise records and documentation to maintain accurate and compliant records of quality agreements and related activities.
- Support customer audits, inspections, and quality discussions as a representative of Lonza, ensuring transparency and compliance during evaluations.
At Lonza, we offer a dynamic and inclusive work environment that encourages growth and development. Our employees enjoy a comprehensive benefits package tailored to role and location, including competitive compensation, health and wellness programs, and opportunities for professional advancement. We promote work-life balance through flexible working arrangements and support ongoing learning through training and development initiatives. Additionally, our global presence provides employees with opportunities for international exposure and career progression. We are committed to fostering a workplace where innovation, collaboration, and integrity thrive, ensuring our team members feel valued and empowered.
Equal Opportunity
Lonza is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based on race, religion, gender, sexual orientation, age, disability, or any other characteristic protected by applicable law. We believe that a diverse workforce enhances our ability to innovate and succeed, and we are dedicated to providing equal employment opportunities to all qualified candidates.
More Info
Job Type:
Industry:
Employment Type:
Key Skills
About Company
