Lead Associate, Quality Audits

Job Description

Job Description

Company Description

At Dr. Reddy's "Good Health Can't Wait"
By joining Dr. Reddy’s, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community.

Diversity, Equity & Inclusion
At Dr. Reddy’s, we are deeply committed to building a diverse, equitable and inclusive workplace where everyone belongs and is valued for their contributions to the team. We are most interested in finding the best candidate for the role and are open to exploring candidates with a less traditional background. Job Description

Job Summary

We are looking for a seasoned Lead Associate, Quality Audits professional who will conduct assessment on company sites, internal GMP (Good Manufacturing Practices) departments, external partners, and quality systems for ensuring compliance with regulatory requirements and expectations, standards, industry trends, and regulatory commitments as well per company policies and procedures. The role involves supporting readiness for regulatory inspection and collaborating across the regional organization to participate in cGMP (current GMP) and GDP (Good Distribution Practice) compliance initiatives and continuous improvement. The role will report to Lead, Quality & Compliance.

Roles & Responsibilities

• You will be responsible for maintaining and enhancing the Supplier management process using quantitative methods to identify high-risk suppliers.
• You will be responsible for conducting detailed assessments of manufacturing processes, quality control procedures, and documentation systems to ensure compliance with established standards.
• You will be responsible for identifying areas for process improvement and recommending corrective actions to enhance efficiency and quality outcomes.
• You will be responsible for conducting audits of external suppliers and vendors to assess their adherence to quality standards.
• You will be responsible for preparing comprehensive audit reports detailing findings, observations, and recommendations for improvement.
• You will be responsible for driving the implementation of quality improvement initiatives based on audit findings and industry advancements.
• You will be responsible for conducting thorough assessments of potential vendors’ quality systems, capabilities, and processes to ensure alignment with organizational quality standards.
• You will be responsible for planning and executing audits of vendors’ quality management systems, manufacturing processes, and facilities to ensure compliance with relevant regulations and industry standards.
• You will be responsible for regular monitoring and analyzing vendor performance data to identify trends and potential issues.
• You will be responsible for communicating quality expectations and vendor-related updates to internal stakeholders, ensuring alignment and understanding across the organization.
• You will be responsible for maintaining Regional Supplier Qualification Reports and Audit Reports. You will prepare and manage Approved Vendors.
• You will be responsible for supporting regulatory compliance oversight of Dr. Reddy’s North America business and identifying areas for correction to eliminate compliance gaps.
• You will be responsible for proactive research of new and upcoming regulations and guidelines.
• You will be responsible for supporting the Regional Quality Council, coordinating compliance metrics for North America and providing periodic updates to Executive Management.
• You will prepare, revise, and execute quality agreements with all vendors in the quality system.
• You may be required to travel domestically and internationally.

Qualifications

Educational qualification: M.S. in Chemistry, Biology or other life sciences; Auditing Certification preferred

Minimum work experience: 8+ years of progressive experience in auditing pharmaceutical or medical device systems, including 2 years of internal and external audit management experience

Skills & attributes:

• Strong understanding of pharmaceuticals, with a combination product or medical device manufacturing, packaging and testing processes, and management of Quality Management Systems.
• Thorough understanding and familiarity with auditing, GMP regulations, including 21 CFR 210, 211, 111, 820, ICH guidelines, IPEC guidelines, FDA guidance documents.
• Understanding of QMS in pharmaceutical manufacturing and packaging facilities and excipients manufacturers.
• Excellent verbal and written communication skills.
• Excellent organizational and time management skills
• Strong attention to detail.
• Strong writing skills for creating technical documents such as Standard Operating Procedures, Summaries, investigation reports, audit reports, and technical change control.

*Must be a U.S. citizen or lawful permanent resident of U.S. or otherwise authorized to work in the U.S. without requiring sponsorship now or in the future.

Additional Information

Our Work Culture
Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.


Equal Opportunity Employer
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against based on disability.

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