Manager, Product Quality

Job Description
We're seeking a Quality Assurance Manager to ensure compliance and efficiency in our quality system for drug, biologics, device, and/or combination products. You'll lead cross-functional teams, design effective quality systems, and coordinate interrelated function activities. You'll support the introduction of new products, identify potential gaps, and oversee training programs. If you're a detail-oriented professional with a strong background in quality assurance and a passion for making a significant impact on our company's success, Apply Now!
Responsibilities:
Ensure proper integration and support of quality regulations:
drug, biologics, device and/or combination products.
Lead project teams in planning, preparation, review and approval of quality documentation.
Responsible for implementing and maintaining the effectiveness of the quality system for drug, biologics, device and/or combination products including compliance with Corporate policies, processes and procedures.
Design effective quality systems, procedures and/or processes within cross functional teams to ensure compliance as well as efficiency throughout our quality system. May be required to prepare and present data during regulatory audits (FDA, EMA, Anvisa, etc) and internal audits.
Manage and oversee the interrelated function activities including design control with R&
D, Manufacturing Scienceand Technology (MS&
T), Supply Chain, Program Management, Commercial, Medical, Pharmacovigilance, and Regulatory Affairs.
Coordinate quality system elements, training, continuous improvement, and tactical support across functions, plants, and affiliates.
Support new product introduction for pharmaceutical products, medical devices, or combination products. Support design changes to existing medical devices and combination products.
Interact with internal and external partners for development of best practices in our quality systems and procedures.
Perform assessments to determine compliance to processes and regulations to identify potential gaps and mitigate and implement improvements within our quality system.
Oversee the implementation and management of training and education programs for various aspects of quality assurance.
Significant Work Activities -Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day).