Manager, Quality Operations

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

The Quality Operations Manager will provide tactical direction to both the on-the-floor quality individuals and the Quality Engineers when issues arise during the manufacturing process.  Additional responsibilities include providing guidance during the investigation process related to incidents that occur during the manufacturing process and assisting with driving quality improvements within the production processes. The role involves liaison with other functional teams such as production, QC Lab, Engineering, external customers, regulatory, and project teams to serve as subject matter expert pertaining to quality operations processes and increasing the site’s quality level.

Role Responsibilities 

• Provide leadership, direction, and support to Quality Improvement Programs within the Quality Operations group using Six Sigma Principles.
• Provide essential support and guidance to Quality on-the-shopfloor and Quality Engineers with respect to technical issues, employee issues, company policy, site processes and Good Manufacturing Practices.
• Maintain the documentation required for their personal EPR process, including training records and the completion of regular reviews for direct reports and input into MTR processes.
• Ensure direct reports receive annual performance appraisals, have regular access to 1:1 sessions, are provided with clear job descriptions of routine accountabilities, plus additional SMART goals and objectives, as well as the development and training plans, as appropriate.
• Routine interaction with external customers and regulatory authorities, through technical interfaces and inspection/audits. Be available to support the Quality Engineers in discussions related to significant quality issues with customers, in compliance with Quality Agreements, and effectively present Kindeva’s position.
• Serve as the management resource for planning the Quality Operations group set through the S&OP process.
• Responsible for the effective management of daily quality and compliance issues, together with developing and executing medium to long-term strategic project plans that align with the site’s business goals, objectives, and requirements.
• Providing meaningful insight and input into management decision making processes, steering teams, and strategic site meetings.
• Champion the development of site compliance programs and training initiatives.  
• Responsible for ensuring that members of the Quality Operations group close deviations, CAPAs and/or audit actions within the established timelines.
• Accountable for financial planning and delivery of agreed-upon department budgetary goals and objectives.

Required skills and experience:  

• Bachelor’s degree or higher in a science discipline
• Minimum 7 years’ experience within a pharmaceutical/medical device manufacturing facility.
• Minimum 5 years’ Supervisory experience
• Demonstrated knowledge of Good Manufacturing Practices and applicable regulations.

#LI-Onsite 

California residents should review our Notice for California Employees and Applicants before applying. 
 
 The expected compensation range for this position represents a good faith estimate. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, & Vision, Health Savings Accounts, Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences, and 401k Benefits, etc.).

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.

Do you see yourself as part of the Kindeva mission? Click Apply Now Today!