Kindeva Drug Delivery · 12 hours ago
Senior Complaint Specialist
Simi Valley, CA
Full-time
Onsite
Senior Level
7+ years expKindeva Drug Delivery is a company focused on creating products that save lives and improve patient health. The Senior Complaint Specialist will provide technical leadership and expertise in overseeing complaint investigations and ensuring compliance with regulatory requirements.
Manufacturing
Responsibilities
Serve as the subject matter expert for Quality Management System (QMS) complaint module
Assist with metric tracking including metrics reported at Tier meetings, monthly reviews, and quarterly reviews (i.e. Quality Management Review)
Review complaints to determine if regulatory reporting is required, and issue reports (i.e. FARs) as required by site procedures, quality agreements, and applicable regulations
Review and assist in complaint investigations and provide corrections and feedback to ensure that investigations are error-free, comprehensive, and aligned with procedural and regulatory requirements
Serve as the complaint trend analyst for the site which includes the following responsibilities: Author complaint trend reports, perform an ongoing analysis of potential emerging trends, assess critical complaints for potential new failure modes and lead meetings to communicate complaint trending to upper management
Provide complaint data, memos, and other requested documentation for PQRs, etc
Contribute to activities related to Post-Market Surveillance, Field Alert Reports, and Adverse Event Reporting
Lead continuous improvement projects relevant to the department
Ensure complaint handling complies with regulatory requirements (i.e. FDA 21 CFR 210, 211, 820, ISO 13485, GMP) and internal procedures
Ensure timely and professional handling of customer concerns
Qualification
Required
Minimum of 7 years work experience in pharmaceutical quality, regulatory or complaint handling roles or Bachelor's (science-based field preferred)
Quality Assurance experience within the pharmaceutical industry
Experience performing product complaint investigations
Experience with product trend analysis
Experience with technical writing
Experience with continuous improvement projects and initiatives
Proficient in Excel and Minitab
Working knowledge of cGMP, ICH guidelines, 21CFR Part 210, 211, 820, EU GMP
Benefits
Medical
Dental
Vision
Health Savings Accounts
Flexible Spending Accounts
Disability Benefits
Life Insurance
Voluntary Benefits
Paid Absences
401k Benefits
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
Bizjournals.com Feed (2025-11-12 15:43:17)
2026-01-16
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2026-01-01
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