Kindeva Drug Delivery · 2 hours ago
Senior Compliance Investigation Specialist
St. Louis County, MO
Full-time
Onsite
Senior Level, Lead/Staff
9+ years expKindeva Drug Delivery is dedicated to making products that save lives and enhance patient health globally. The Senior Compliance Investigation Specialist will oversee the management of Manufacturing Investigation Reports and Corrective and Preventive Actions, ensuring compliance with quality standards and leading process improvement initiatives within Sterile Product Manufacturing operations.
Manufacturing
Responsibilities
Completes and facilitates completion of Manufacturing Investigation efforts within SPM to ensure compliance with quality and cycle time standards
Provides guidance, coaching and feedback to all groups involved in initiating, completing and conducting manufacturing investigations and CAPA analysis
Gathers and analyzes historical data to identify trends and root-cause of manufacturing deviations
Develops and recommends corrective and preventive actions to prevent/eliminate recurrent discrepancies and leads its implementation in manufacturing
Ensures that QAR system requirements M1/PHP are being executed as established in the site’s Standard Operating Procedures (SOP) and other guidelines
Acts as the primary contact in the resolution of conflicts and differences resulting from the resolution of MIRs
Collaborates in the design and deployment of trainings to educate employees on how to report, initiate, conduct and close an investigation
Leads efforts to educate leaders and employees on OPEX methods, practices and tools
Leads process improvement initiatives that increase quality/compliance, efficiency and safety within the Sterile Product Manufacturing facility
Qualification
Required
The successful candidate will have a minimum of nine years of applicable experience and a BA/BS/MS degree in Engineering, Chemistry, Physical/Biological Sciences, Business, Integrated Supply Management, or related applicable discipline that will enable the team to meet its mission
Effective team building skills
Proven leadership and change management abilities
Ability to effectively coach and mentor colleagues
Strong oral and written communication skills
Ability to influence at all levels of the site
M1 and PHP education and experience
Lean Six Sigma education and experience
Ability to connect the mission of the team to site goals
Preferred
Green/Black belt certification is highly desired
Strong background in GMP Manufacturing, QA/QC, Aseptic Manufacturing and/or Environmental Monitoring is highly desirable
Company
Kindeva Drug Delivery
Kindeva Drug Delivery is a global contract development and manufacturing organization (CDMO) in the pharmaceutical industry.
1001-5000 employees
H1B Sponsorship
Kindeva Drug Delivery has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (4)
2023 (1)
2022 (3)
Funding
Current Stage
Late StageTotal Funding
$46.96MKey Investors
Global Britain Investment Fund
2023-08-03Grant· $41.96M
2022-11-14Acquired
2022-06-13Series Unknown· $5M
Leadership Team
Brian Schubmehl
Chief Human Resources Officer
Recent News
2026-01-16
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2026-01-16
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2026-01-01
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