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 well-being of people worldwide. With over 30 sites across five continents, Lonza's diverse and interconnected teams work collaboratively to produce the medicines and therapies of tomorrow. Our core values—Collaboration, Accountability, Excellence, Passion, and Integrity—guide our operations and foster a culture of innovation and ethical responsibility.
We believe that every idea, no matter how small, has the potential to make a significant impact on millions of lives, and we are committed to empowering our employees to contribute to this mission.
Lonza values diversity and inclusion, recognizing that diverse perspectives drive innovation and better solutions. We strive to create an inclusive environment where all employees feel valued and empowered to bring their unique backgrounds and experiences to the table. Our commitment to sustainability, quality, and continuous improvement ensures that we remain at the forefront of the life sciences industry, helping our clients turn breakthrough ideas into viable therapies.
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 regulatory frameworks, quality standards, and contractual obligations, while also managing site-specific negotiations and implementations.
The role offers a unique opportunity to influence quality compliance across multiple regions, supporting continuous improvement initiatives and driving harmonization of processes. The successful candidate will serve as a subject matter expert, providing guidance on compliance issues, managing documentation,
and representing the company during audits and inspections. This role is ideal for professionals who excel in negotiation, stakeholder management, and problem-solving within a dynamic, fast-paced environment.
Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or a related field; advanced degrees are preferred.
- Minimum of 5 years of experience in quality assurance, compliance, or a related role within the pharmaceutical or biotech industry.
- Strong understanding of Good Manufacturing Practices (GMP), regulatory requirements, and quality standards.
- Proven experience in negotiating and managing quality agreements with global customers.
- Excellent communication and negotiation skills, with fluency in English (spoken and written).
- Ability to analyze complex regulatory and contractual requirements and translate them into actionable processes.
- Strong organizational skills, with the ability to prioritize and manage multiple projects simultaneously.
- Proficiency in quality management systems and tools, such as TrackWise or similar platforms.
- Experience working in a multicultural and cross-functional environment.
Responsibilities
- Support and execute timely negotiations with global customers to define, align, and finalize quality agreements (QAAs) for Lonza, ensuring compliance with GMP and other relevant regulations.
- Verify that all customer QAAs meet the minimum requirements established by Lonza and maintain alignment with internal quality standards.
- Act as the primary point of contact for internal stakeholders regarding all matters related to QAAs, facilitating clear communication and collaboration.
- Coordinate with cross-functional teams, including Legal, Quality, Operations, and Commercial, to ensure consistent and effective implementation of QAAs.
- Manage the preparation, review, and periodic updates or withdrawal of QAAs, ensuring accuracy and compliance throughout the process.
- Contribute to continuous improvement initiatives by analyzing workflows, proposing optimizations, and supporting the implementation of digital tools and automation to enhance efficiency.
- Ensure alignment between internal processes and contractual commitments outlined in QAAs, promoting consistency across the organization.
- Collaborate with global Quality teams and other sites to harmonize processes, share best practices, and increase operational efficiency.
- Provide expert guidance and knowledge sharing on compliance topics, serving as a subject matter expert for the business unit and other sites.
- Support customer audits, inspections, and quality-related discussions as a compliance representative, ensuring readiness and effective communication.
Benefits
- Opportunity to work in an agile and dynamic environment that fosters professional growth and development.
- Inclusive and ethical workplace culture that values diversity and promotes collaboration.
- Competitive compensation packages that recognize high performance and dedication.
- A comprehensive benefits program tailored to the role and location, including health insurance, retirement plans, and wellness initiatives.
- Relocation assistance available for eligible candidates and their families, supporting a smooth transition to Hyderabad, India.
- Access to global learning resources, training programs, and career advancement opportunities.
Equal Opportunity Lonza is an equal opportunity employer committed to creating an inclusive setting for all employees. We celebrate diversity and are dedicated to providing equal employment opportunities regardless of race, color, religion, gender, sexual orientation, gender identity or expression, age, national origin, disability, or any other protected characteristic. We believe that a diverse workforce enhances innovation and drives our success, and we are committed to fostering a workplace where everyone can thrive.
📌 Quality Senior Professional (India)
🏢 FetchJobs.co
📍 India