Quality Professional - Customer Compliance (India)

Quality Professional - Customer Compliance (India)

18 Aug
|
FetchJobs.co
|
India

18 Aug

FetchJobs.co

India

About The Company

Lonza is a global leader in the life sciences industry, dedicated to developing and manufacturing innovative solutions that improve the health and wellbeing of people worldwide. With over 30 sites across five continents, Lonza’s diverse and interconnected teams work collaboratively to produce medicines, vaccines, and advanced biotechnological products. Our commitment to quality, sustainability, and technological advancement positions us at the forefront of the industry, enabling us to support our customers’ most ambitious projects.

At Lonza, we believe that our people are our greatest strength, and we foster an inclusive environment that values diversity, creativity, and integrity. We are passionate about turning groundbreaking ideas into real-world therapies that can transform lives and shape the future of healthcare.

About The Role The Quality Senior Professional, Customer Compliance & QAAs at Lonza plays a vital role in ensuring that quality agreements (QAAs) and related processes adhere to regulatory standards, contractual obligations, and organizational policies. This position involves actively supporting quality negotiations with global customers and facilitating alignment between internal stakeholders and external clients. The role operates at a global level, providing support across multiple sites while accommodating site-specific negotiations and requirements.

The successful candidate will be responsible for managing and updating QAAs, ensuring compliance with Good Manufacturing Practices (GMP), and contributing to continuous improvement initiatives within quality compliance processes. This role offers an excellent opportunity to work in a energetic environment, collaborating with cross-functional teams to uphold the highest standards of quality and compliance in the life sciences industry.

Qualifications

- Bachelor’s degree in Life Sciences, Quality Assurance, Pharmacy, or a related field. Advanced degrees are a plus.
- Proven experience in quality assurance, regulatory compliance,



or customer quality agreements within the pharmaceutical or biotechnology industry.
- Strong understanding of GMP regulations, ISO standards, and contractual quality requirements.
- Excellent negotiation, communication, and interpersonal skills.
- Demonstrated ability to analyze complex regulatory and contractual documents and interpret their implications.
- Experience with quality management systems and tools such as TrackWise or similar platforms.
- Ability to manage multiple priorities effectively and work collaboratively across functions.
- Fluent in English, both spoken and written, with exceptional communication skills.

Responsibilities

- Support and execute timely negotiations with global customers to define, align, and finalize quality agreements (QAAs) for Lonza, ensuring compliance with regulatory and contractual standards.
- Maintain and update QAAs regularly, overseeing periodic reviews and withdrawal processes as necessary.
- Ensure all QAAs meet the minimum requirements established by Lonza, GMP standards, and other relevant regulations.
- Serve as the primary point of contact for internal stakeholders regarding all QAA-related matters, fostering clear communication and collaboration.
- Coordinate with cross-functional teams including Legal, Quality, Operations, and Commercial to ensure seamless implementation and adherence to QAAs.
- Prepare and manage updates to QAAs, facilitating smooth transitions during reviews or terminations.
- Contribute to continuous improvement initiatives by analyzing current workflows, proposing process optimizations, and supporting the implementation of digital tools and automation solutions.




- Ensure consistency between internal processes and commitments outlined in QAAs, driving harmonization across global sites.
- Collaborate with global quality teams and other sites to identify opportunities for process improvements and increased efficiency.
- Provide expert guidance on compliance topics, sharing knowledge across the organization to enhance awareness and adherence to quality standards.
- Manage TrackWise records related to QAAs and other compliance documentation as required.
- Support the organization during customer audits, inspections, and quality discussions, representing Lonza’s commitment to quality and compliance.

Benefits At Lonza, we offer a comprehensive perks package designed to support our employees’ health, wellbeing, and professional growth. Our benefits include competitive salary packages, performance-based incentives, health and wellness programs, and opportunities for continuous learning and development. We promote a flexible work environment that balances office presence with work from home options, fostering a healthy work-life balance. Additionally, our global benefits program includes retirement plans, insurance coverage, and employee assistance programs tailored to regional needs. We are committed to creating an inclusive workplace where everyone can thrive and contribute to our shared success.

Equal Opportunity

Lonza is an equal opportunity employer committed to fostering an inclusive environment for all employees. We do not discriminate based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, or any other protected characteristic. We believe that diversity drives innovation and excellence, and we are dedicated to providing equal employment opportunities to all qualified candidates.

We encourage individuals from diverse backgrounds to apply and join our team as we work together to shape the future of life sciences.

📌 Quality Professional - Customer Compliance (India)
🏢 FetchJobs.co
📍 India

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