Quality Operations Manager

Kindeva Drug Delivery

Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.

POSITION SUMMARY

The Quality Operation Manager will be responsible for the overall management of the Quality Operations group, which includes Quality on-the-ship-floor and Quality Engineering, ensuring all activities are in compliance with regulatory regulations/guidance and company standards.

The Quality Ops Manager will provide tactical direction to both the on-the-floor quality individuals and the Quality Engineers, when issue arise during the manufacturing process.  Additionally, they will provide guidance with investigations related to incidents that occur during the manufacturing process.  The Quality Ops Manager will also assist with driving quality improvements in the production processes. The role involves liaison with production, QC Lab, external customers, regulatory and project teams to provide expertise on quality operations processes.

Role accountable for ensuring all timelines are met, establishing, and managing budgets for the Quality Ops group. Partners with engineering, production, and other site functions to maintain and increase the quality level with organization.

ROLE RESPONSIBILITIES

• Provide leadership, direction, and support to Quality Improvement programs within Quality Operations using Six Sigma
• Support and guidance to Quality on-the-shop-floor and Quality Engineers with regards technical issues, employee issues, company policy, site processes and GMP.
• Maintain the documentation required for their personal EPR process, including training record and complete regular reviews for direct reports and input into MTR processes.
• Ensure direct reports are appraised, have regular access to 1:1 session, have clear job descriptions of routine accountabilities plus additional SMART objectives as well as development and training plans as appropriate.
• Interact with 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 to present Kindeva position.
• Management of resource planning for the Quality Operation group set through S&OP process and effectively manage daily quality and compliance issues together with medium to longer term strategic project plans in line with business requirements.
• Preparation and input into Management decision making processes, steering teams, and strategic site meetings.
• Champion and development of site compliance programs and training
• Responsible to ensure that members of the Quality Operations group close deviations, CAPAs and/or audit actions on time
• Accountable for financial planning and delivery of agreed department budgets

BASIC QUALIFICATIONS

• Bachelors degree or higher in an engineering or science discipline
• Minimum 10 years’ quality experience within a pharmaceutical or medical device industry
• Minimum 5 years’ Supervisory experience or experience leading a team

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