Supervisor, Manufacturing Quality Assurance

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make:

Responsibilities:

• Lead the development, implementation and management of GMP quality and compliance systems and policies, including the timely development of QA processes and procedures
• Leads the day-to-day activities of the QA group with respect to the writing, review and approval of GMP documentation.
• Participate in all plant activities and leads continuous improvement objectives to ensure cGMP compliance.
• Advises management on findings and recommendations related to internal and external auditing and implements changes
• Reviews, and approves cGMP documentation including procedures, batch records, validation protocols, development reports, specifications and other related documents.
• Oversee the deviation and events management system.
• Develop and implement training qualification programs for QA team members.
• Develops and maintains metrics and trending reports for Compliance-related activities.
• Reviews and approves product complaint investigations and assists with investigations.
• Leads activities associated with various one-time or on-going projects (from participation level to project manager).
• Collaborates with departments and external suppliers regarding quality concerns.
• Participates and/or coordinates Compliance Assessments of departments as necessary (GXP, Part 11, etc.).
• Leads regulatory inspections and customer audits.
• Assist Manager with daily and project activities as needed.
• Maintain current knowledge of new regulatory developments.
• Other duties as assigned.

Qualifications:

Basic Qualifications:

• Bachelor’s degree in a scientific discipline preferred or equivalent experience.
• At least 6 years Pharmaceutical/Medical Device cGMP quality experience
• Excels in organizational and leadership skills and attention to detail
• Superior interpersonal and communication skills and demonstrated ability to effectively communicate with all levels of the organization
• Familiar with the necessary components of facility qualification and validation activities.
• Extensive knowledge of cGMP regulations and ICH guidelines.
• Must be flexible, adaptable, self-motivated and able to work well independently and across teams and partners
• Ability to work in a lean, action oriented organization and demonstrate a strong work ethic
• Ability to identify the need for and implement change while inspiring confidence and enthusiasm within the team
• Qualified to work with controlled substances

Physical Requirements:

• Regular use of hands for documentation, equipment operation, and material handling
• Extended periods of standing and walking
• Ability to lift/move
• Full range of vision capabilities (close, distance, color, peripheral, depth)
• Must wear required PPE and follow cGMP/safety procedures
• Lift heavy equipment up to 60 pounds occasionally, climb ladders, and work in confined spaces.

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