Top 13 Regulatory affairs & quality manager Jobs in Tecumseh, Mi

Sr Manager, Quality Control – Drug Device Combination Products
ESPERION THERAPEUTICS INC —Ann Arbor, MI
- $166,500 - $175,000 a year
- Remote
- Management
- Laboratory experience
- Microsoft Office
- Paid holidays
- Health insurance
Quick Apply
Sr Mgr, QA/Quality Engineer, Device & Combination Products
ESPERION THERAPEUTICS INC —Ann Arbor, MI
- $166,500 - $175,000 a year
- Remote
- Laboratory experience
- Microsoft Office
- Travel
- Paid holidays
- Health insurance
Quick Apply
Regulatory Affairs & Quality Manager
Spike Neuro —Ann Arbor, MI
- $90,000 - $140,000 a year
- Full-time
- Engineering
- English
- Office
- Health insurance
- Dental insurance
Quick Apply
Sr. Engineer, Regulatory Affairs and Certification, Vehicle Safety
Mitsubishi Motors North America, Inc. —Ann Arbor, MI
- Remote
- 5 years
- Word processing
- Computer literacy
- Work from home
Mgr, Drug Product Development & Manufacturing
ESPERION THERAPEUTICS INC —Ann Arbor, MI
- $138,000 - $176,000 a year
- Remote
- English
- Mid-level
- Continuous improvement
- Paid holidays
- Health insurance
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Clinical Case Manager
Eisenhower Center —Ann Arbor, MI
- $55,000 - $65,000 a year
- Adults
- LPC
- Mid-level
- Disability insurance
- Health insurance
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Maintenance Supervisor-Lab Operations R&D
Toyota —Ann Arbor, MI
- Overtime
- Customer service
- Engineering
- Mid-level
- Health savings account
- Paid holidays
Supervisor - Inpatient Clinical Documentation Integrity
University of Michigan —Ann Arbor, MI
- Full-time
- Remote
- Background check
- Nursing
- RN License
- Health insurance
- Dental insurance
7d
Branch Manager
Johnstone Supply LLC —Ann Arbor, MI
- Full-time
- 5 years
- Merchandising
- Basic math
Quick Apply
Registered Nurse - 5 Central Surgical PCU Nurse Manager
US Veterans Health Administration —Ann Arbor, MI
- $105,038 - $152,267 a year
- Online Application
- Background check
- Nursing
- Doctoral degree
- Paid holidays
- Dental insurance
3d
Registered Nurse - 5 Central Surgical PCU Assistant Nurse Manager
US Veterans Health Administration —Ann Arbor, MI
- $87,812 - $146,393 a year
- Online Application
- Background check
- Nursing
- Doctoral degree
- Paid holidays
- Dental insurance
3d
Medical Assistant, EverCare
Hospice of Michigan —Ann Arbor, MI
- Full-time
- Writing skills
- Medical office experience
- BLS Certification
- Vision insurance
Quick Apply
Field Clinical Specialist, Michigan East- Transcatheter Heart Valve
Edwards Lifesciences —Ann Arbor, MI
- Full-time
- Nursing
- Clean driving record
- Hospital
2d

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Sr Manager, Quality Control – Drug Device Combination Products

ESPERION THERAPEUTICS INC
Ann Arbor, MI

Quick Apply

Job Details

$166,500 - $175,000 a year

Benefits

Paid holidays
Health insurance
Paid time off
401(k) matching

Qualifications

Regulatory inspections
Stability testing
Management
Stability studies in drug product development
Medical device testing
Laboratory experience
GMP
Project management experience in manufacturing
Microsoft Office
ICH guidelines
Biomedical regulatory compliance
Managing projects
Verification of laboratory test methods
Quality control experience within pharmaceutical industry
Quality audits
Laboratory information systems (LIS)
Test validation method
Technical Proficiency
Project stakeholder communication
Validation design
Pharmaceutical manufacturing facility experience
Stakeholder management

Full Job Description

Company Overview

Our Mission: At Esperion, we are working tirelessly to deliver innovative medicines that help patients reach their goals today, tomorrow, and into the future.

Esperion Quality Philosophy: Quality is in all we do because all we do is for our patients.

Esperion’s passion for quality is an integral part of our company culture and is embedded in every aspect of the organization. We are committed to applying the highest quality standards to develop and deliver safe, effective pharmaceutical products that significantly improve the quality of life for the patients and clinical trial participants we serve.

Esperion is a fully remote‑based company with a corporate headquarters located in Ann Arbor, MI. The Company offers a competitive salary including a performance‑based bonus program, a comprehensive benefits package including a 401(k) matching plan and health insurance, and paid time off and holidays.

Position Title: Senior Manager, Quality Control – Drug‑Device Combination Products

Quality Control is responsible for pre-commercial development and commercial activities including the operational aspects of commercial drug device combination product, drug substance, device and packaging components. This work includes release testing, stability programs, methods transfers, and validations at external laboratories and Contract Development and Manufacturing Organizations (CDMOs).

This position serves as a Quality Control subject matter expert for combination products, ensuring appropriate control strategies are in place for drug substance, drug product, and device components, and partners closely with Quality Assurance, Regulatory Affairs, Technical Operations, and external partners to maintain inspection readiness.

Preferred Location: Remote – US

Essential Duties and Responsibilities*

Provide in‑depth technical and scientific leadership to contract service providers and internal stakeholders related to Quality Control for drug–device combination products.
Serve as the primary QC technical and project management liaison with CDMOs and external testing laboratories supporting drug substance, drug product, and device component testing.
Review and approve development, release, and stability data for routine manufacturing, investigations, and deviations involving drug substance, drug product, and combination products.
Design, implement, and maintain Quality Control processes for specifications, analytical methods, protocols, and reports, both internally and externally.
Recommend and justify product specifications and test methods appropriate to phase of development and product risk, including combination product considerations.
Ensure testing and release activities are executed in alignment with established schedules, quality requirements, and budget commitments.
Provide QC input and support for combination product design‑related activities, including verification/validation testing support as applicable.
Support regulatory submissions and act as a QC lead during FDA, EU, and partner audits and inspections, including those involving combination product or device‑related scope.
Partner with Quality Assurance on investigations, change controls, CAPAs, and risk assessments.
Support qualification of alternate manufacturing sites, laboratories, service suppliers, and device component suppliers.
Review and approve stability protocols and reports prepared by CMOs; ensure compliance with ICH stability guidelines and applicable drug-device combination product requirements.
Review, trend, and interpret drug substance, drug product, and combination product data and contribute to Annual Product Reviews.
Review and approve analytical methods, method validation/verification protocols, and reports.
Lead or co‑lead cross‑functional Technical Operations projects and CMO oversight activities.
Track, trend, and report compliance metrics and quality performance indicators; recommend and implement supplier performance metrics.
Additional duties and responsibilities as assigned.

Qualifications (Education & Experience)

Required Qualifications

Bachelor’s degree in Chemistry, Biology, Engineering, or a related scientific discipline.
8+ years of progressive Quality Control experience within the medical device or drug–device combination product industry.
Direct experience supporting medical devices and/or drug–device combination products in a regulated GxP environment.
Strong working knowledge of:
- 21 CFR Parts 210/211 (cGMPs)
- 21 CFR Part 4 (Combination Products)
- ISO 13485
- Applicable elements of 21 CFR Part 820
Experience leading QC method transfers and validations at external CMOs and testing laboratories.
Proven experience managing global external CDMOs and contract testing laboratories.
Solid understanding of ICH guidelines, including stability testing requirements for pharmaceutical and combination products.
Experience supporting regulatory inspections and audits, including preparation and response activities.
Strong project management, communication, and stakeholder‑influencing skills in a matrixed environment.

Preferred Qualifications

Experience working within ISO 13485‑aligned quality systems.
Experience supporting EU MDR or global device regulatory submissions.
Background supporting combination products such as prefilled syringes, autoinjectors, or other delivery systems.
Experience contributing to CMC sections of U.S. or EU regulatory filings involving combination products.
Familiarity with data integrity requirements and lifecycle management of analytical methods for combination products.

Additional Requirements

Proficiency with MS Office and laboratory and quality systems (LIMS, QMS, EDMS).
Demonstrated alignment with Esperion’s values and culture.
Ability to work effectively in a fully remote environment.
Moderate domestic and international travel required (up to 20% annually).

Quick Apply

Refine Your Search

regulatory affairs & quality manager jobs in tecumseh, mi

Sr Manager, Quality Control – Drug Device Combination Products

Sr Mgr, QA/Quality Engineer, Device & Combination Products

Regulatory Affairs & Quality Manager

Sr. Engineer, Regulatory Affairs and Certification, Vehicle Safety

Mgr, Drug Product Development & Manufacturing

Clinical Case Manager

Maintenance Supervisor-Lab Operations R&D

Supervisor - Inpatient Clinical Documentation Integrity

Branch Manager

Registered Nurse - 5 Central Surgical PCU Nurse Manager

Registered Nurse - 5 Central Surgical PCU Assistant Nurse Manager

Medical Assistant, EverCare

Field Clinical Specialist, Michigan East- Transcatheter Heart Valve

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