14 Aug
|
FetchJobs.co
|
India
14 Aug
FetchJobs.co
India
About The Company
Lonza is a leading global provider of integrated healthcare solutions, specializing in the development and manufacturing of pharmaceuticals, biotech products, and specialty chemicals. 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 sustainability drives us to push the boundaries of science and technology, enabling our customers to bring their breakthrough therapies and treatments to market.
At Lonza, we believe that our people are our greatest asset, and we foster a culture that values diversity, inclusion, and continuous learning. Join us in shaping the future of life sciences and making a meaningful impact on global health.
About The Role The position of Quality Senior Professional, Customer Compliance & QAAs at Lonza is a vital role dedicated to ensuring the integrity and compliance of quality agreements (QAAs) and related processes. This role involves supporting global customer negotiations, aligning internal stakeholders, and maintaining adherence to regulatory, contractual, and organizational standards. The successful candidate will operate at a global level, providing expert guidance on quality compliance, facilitating continuous improvement initiatives, and representing Lonza during customer audits and inspections.
This role requires a proactive approach to managing quality agreements, optimizing workflows, and fostering collaboration across multiple departments to uphold Lonza’s commitment to quality and compliance.
Qualifications The ideal candidate will possess a strong background in quality management within the pharmaceutical or biotech industry, with demonstrated experience in negotiating and managing QAAs. A bachelor’s degree in life sciences, pharmacy, chemistry, or a related field is required; a master’s degree or higher is preferred. Candidates should have extensive knowledge of GMP regulations,
quality systems, and regulatory standards.
Excellent communication, negotiation, and stakeholder management skills are essential, along with a proven ability to analyze complex regulatory requirements and interpret contractual obligations. Proficiency in English, both spoken and written, is mandatory. Prior experience with digital tools such as TrackWise or similar quality management systems will be considered an advantage.
The ability to work effectively in a cross-functional environment and manage multiple priorities is crucial for success in this role.
Responsibilities
- Support and execute timely negotiations with global customers to define, align, and finalize Customer QAAs for Lonza, ensuring compliance with GMP and other relevant regulations.
- Maintain up-to-date quality standards and procedures to ensure all QAAs meet minimum Lonza requirements and contractual obligations.
- Serve as the primary point of contact for internal stakeholders on all QAA-related matters, facilitating clear communication and collaboration across departments.
- Coordinate with cross-functional teams including Legal, Quality, Operations, and Commercial to ensure consistent implementation and adherence to QAAs.
- Prepare and manage updates to QAAs, including periodic reviews, amendments, or withdrawal of agreements as necessary.
- Contribute to continuous improvement initiatives by analyzing workflows, proposing process optimizations, and supporting the implementation of digital tools and automation to enhance efficiency.
- Ensure alignment between internal processes and commitments outlined in QAAs,
driving harmonization across global sites.
- Collaborate with global Quality teams and other sites to share best practices, streamline processes, and promote compliance awareness throughout the organization.
- Provide expert guidance and knowledge sharing on compliance topics, serving as a subject matter expert and managing TrackWise records as required.
- Support and represent Lonza during customer audits, inspections, and quality discussions, ensuring readiness and compliance with regulatory expectations.
Benefits At Lonza, we offer a dynamic and inclusive work environment that fosters professional growth and development. Our compensation packages are designed to recognize high performance and include a variety of benefits tailored to role and location. Employees can expect comprehensive health insurance, retirement plans, paid time off, and wellness programs. We also provide opportunities for continuous learning through training programs, workshops, and career advancement initiatives. Our flexible work arrangements, including remote work options, support work-life balance. Additionally, being part of a global organization offers exposure to diverse projects, international teams, and innovative technologies that can elevate your career to new heights.
Equal Opportunity
Lonza is committed to creating a diverse and inclusive workplace where all employees are valued and respected. We provide equal employment opportunities regardless of race, gender, age, religion, national origin, disability, sexual orientation, or any other protected characteristic. We believe that a diverse workforce enhances innovation and drives better business outcomes.
Our commitment to equal opportunity extends throughout our hiring, promotion, and development processes, ensuring a fair and equitable workplace for all employees. Join us in our mission to improve global health and contribute to a culture of integrity and respect.
📌 Quality Expert Professional (India)
🏢 FetchJobs.co
📍 India