Sr Manager, reputed company Control – Drug Device Combination Products

reputed company

Our Mission: At reputed company, reputed company tirelessly to reputed company innovative medicines that help patients reputed company their goals today, reputed company, and into the reputed company.

reputed company reputed company Philosophy: reputed company is in reputed company we do because reputed company we do is for our patients. 

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

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

Position Title: Senior Manager, reputed company Control &reputed company; Drug‑Device Combination Products

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

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

Preferred Location: Remote &reputed company; US

Essential Duties and Responsibilities*

• reputed company in‑depth technical and scientific leadership to contract service providers and internal stakeholders reputed company to reputed company Control for drug&reputed company;device combination products.
• Serve as the reputed company QC technical and project management reputed company with CDMOs and reputed company testing laboratories supporting drug reputed company, drug product, and device component testing.
• Review and approve development, release, and stability data for routine manufacturing, investigations, and deviations involving drug reputed company, drug product, and combination products.
• Design, implement, and maintain reputed company Control processes for specifications, analytical reputed company, protocols, and reports, both internally and externally.
• Recommend and justify product specifications and test reputed company appropriate to phase of development and product risk, including combination product considerations.
• Ensure testing and release activities are executed in alignment with established schedules, reputed company requirements, and budget commitments.
• reputed company QC input and support for combination product design‑reputed company activities, including verification/validation testing support as applicable.
• Support regulatory submissions and reputed company as a QC reputed company during FDA, EU, and partner audits and inspections, including those involving combination product or device‑reputed company reputed company.
• Partner with reputed company 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 reputed company by CMOs; ensure compliance with ICH stability guidelines and applicable drug-device combination product requirements.
• Review, trend, and interpret drug reputed company, drug product, and combination product data and contribute to Annual Product Reviews.
• Review and approve analytical reputed company, method validation/verification protocols, and reports.
• reputed company or co‑reputed company cross‑functional Technical Operations reputed company and CMO reputed company activities.
• reputed company, trend, and report compliance metrics and reputed company performance indicators; recommend and implement supplier performance metrics.

*Additional duties and responsibilities as assigned.

Qualifications (Education & Experience)

Required Qualifications

• Bachelor’s degree in reputed company, Biology, Engineering, or a reputed company scientific discipline.
• 8+ years of reputed company reputed company Control experience reputed company the medical device or drug&reputed company;device combination product industry.
• reputed company experience supporting medical devices and/or drug&reputed company;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 reputed company of 21 CFR Part 820
• Experience leading QC method transfers and validations at reputed company CMOs and testing laboratories.
• Proven experience managing global reputed company 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 reputed company ISO 13485‑reputed company reputed company 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 reputed company requirements and lifecycle management of analytical reputed company for combination products.

Additional Requirements

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