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.

# LI-Onsite

California residents should review our Notice for California Employees and Applicants before applying. 
 
 

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

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