Quality Assurance Manager

Our client, a prestigious healthcare/high tech company, based out of Cambridge and Woburn, needs an accomplished Quality Assurance Manager to assist with strategies, review, management, and oversight, to help bring their products and technologies to the next level. This is a contract temp-to-perm onsite opportunity. You will mainly be operating out of the organization’s Woburn office, with some travel required.

As an experienced Quality Assurance Manager, you will:  

• Provide strategic direction and oversight for the management and development of the Quality Management System to support combination product development and commercialization.
• Be responsible for the ongoing review, strategy development, and operational planning to ensure that all quality assurance programs meet applicable regulations and standards.
• Execute the evolution of quality systems to meet the requirements of the various drug product development stages.
• Partner with GXP Operations to assist in oversight of contract service providers.
• Assist Regulatory Affairs in the preparation and review of product development data for regulatory submissions
• Implement pre-approval inspection readiness program.
• Manage individual and group workloads to meet campaign objectives.
• Write and revise Standard Operating Procedures.
• Review and approval of Data.
• Be responsible for the company’s Equipment and Metrology programs.
• Maintain an ongoing understanding of and adaptation to the pharmaceutical, biologics, and medical device industries including staying abreast of quality issues within industry and government.

Preferred Experience

• Bachelor’s degree in Life Sciences field
• 3 to 5 years in Quality Assurance, in the medical device, biologics and/or pharma industries; or 7+ years working in a GXP Environment.
• Experience in pharmaceutical, biological, and combination product development from preclinical drug development through commercialization preferred.
• Knowledge of GXP environments.
• Quality management of contract service providers (agreements, audits, specification setting, product release).
• Creative approach to problem-solving.
• Strong knowledge of product development technical strategy as well as systems strategy; must also be able to tie technical and systems strategies into the overall business strategy.
• Experience in managing regulatory inspections.
• Experience in performing audits of suppliers.
• Demonstration of high-level leadership skills.
• Excellent written and verbal communication skills.
• Excellent skills in managing technical and human resources.
• Experience in supporting the development of data for regulatory applications and submissions.
• Experience in leading pre-approval inspection readiness activities.

Personal Skills/Attributes/Qualifications

• Timeliness in achieving deliverables
• Organizational skills
• Superior written and verbal communication skills
• Collaborative leader
• Strong negotiating, influencing and problem-solving skills
• Ability to productively interact with contracted service providers and representatives of various government auditing agencies
• Detail oriented and hands on in the work environment

Travel: <25%

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