Specialist QA, Global Supply Quality

Roles Responsibilities:

• Perform tactical batch disposition activities in support of lot release.
• Enter and approve analytical data in LIMS.
• Review and approve batch record and production documentation.
• Initiate Quality records for supplier related changes.
• Collaborate with global complaints team to request supplier assessments and review and approve associated investigations.
• Travel to regional suppliers and Contract Manufacturers in India to support person-in-plant activities, routine quality oversight, and audit activities.
• Provide data to the global networks to support Quality Management Processes.
• Prepare, review and approve SOPs and other GMP/GDP documentation in compliance with corporate and regulatory requirements, to ensure alignment with procedures, current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
• Take part in operational and quality improvement initiatives, programs, and projects.
• Communicate effectively with stakeholders, ensuring alignment on quality objectives and compliance needs.
• This role may require working in shifts or extended hours within the same shift to support global time zones.

Basic Qualifications and Experience:

• Masters / Bachelor''s degree with 8 to 12 years of experience in quality management systems or a related field OR
• Bachelors degree with 6 to 8 years of experience in quality management systems or a related field OR
• Diploma with 8+ years of experience in quality management systems or a related field.

Functional Skills:

Must-Have Skills:

• Working foundation in quality assurance roles.

• Minimum of4yearsworking in a cGMP manufacturing environment with a strong understanding of regulatory requirements and expectations.

• Ability to have a positive impact on others; the ability to affect the behaviors of others by connecting with and inspiring them.

Good-to-Have Skills:

• Experience in investigations, projectmanagement and trendingand analysis.

• Relevant experience in Supplier Managementand/orcontract manufacturingoversight.

• Understanding ofthe applicable manufacturing/testing processes (i.e.API, Drug Substance, Drug Product, Packaging).

• Proven experience in designing and/or improving processes.

• Desire to partner with internal and external stakeholders across teams.

• Understanding ofindustry requirements/expectations of a robust Quality Management System and documentation.
• Experience with Microsoft Office Tools including Excel, Word, and PowerPoint, Power BI

Soft Skills:

• Excellent analytical and troubleshooting skills.

• Strong verbal and written communication skills

• Ability to work effectively with global, virtual teams

• High degree of initiative and self-motivation.

• Ability to manage multiple priorities successfully.

• Team-oriented, with a focus on achieving team goals

• Strong presentation and public speaking skills.