Senior Manager Quality Operations

Reporting to the Director, Quality Operations US (Molecular Imaging Platform), the Senior Manager Quality Operations, US will be responsible for managing the quality operations of Blue Earth Diagnostics’ U.S. based third-party Contract Manufacturing Organization (CMO) network. The position requires operational oversight and cross-functional collaboration to maintain a robust and consistent supply of quality products in accordance with regulatory requirements.

The successful candidate will be required to work in a hybrid working arrangement, including three days a week in the Needham, Massachusetts office, and two days a week of remote work.

Main Responsibilities, Activities, Duties and Tasks

• Serve as the primary quality point of contact for U.S.-based Contract Manufacturing Organizations (CMOs), overseeing manufacturing performance and resolution of quality-related issues.
• Ensure appropriate documentation and maintenance of quality oversight records, including routine monitoring and follow-up actions.
• Review and approve CMO investigation reports to ensure technical accuracy, regulatory compliance, and effective root cause analysis.
• Lead routine quality meetings with CMOs to discuss performance, deviations, ongoing improvements, and escalations.
• Perform ongoing trending and analysis of CMO quality metrics to proactively identify risks and drive continuous performance improvement.
• Conduct scheduled CMO audits in accordance with the annual audit schedule.
• Support the continuous enhancement of the Blue Earth Diagnostics (BED) Quality Management System (QMS), including SOP revisions, process optimization, and alignment with global standards.
• Contribute to the development and presentation of Quality Assurance metrics and reports for Quality Management Review (QMR).
• Provide support as the GMP Quality representative on cross-functional project teams, providing guidance during development, scale-up, and operational transitions.
• Monitor regulatory changes related to U.S. PET and pharmaceutical manufacturing, quality, and distribution; evaluate impact and initiate updates to internal processes as needed.
• Assess, document, and track complaints, deviations, and CAPAs to ensure timely, thorough, and effective resolution and preventive action.
• Ensure full compliance with all applicable aspects of the BED Quality Management System and regulatory requirements.

Education

A degree in a science related discipline or greater than 7 years relevant industry experience.

Professional Experience, Knowledge & Technical Skills

• Minimum of 5 years of progressive experience in Quality Assurance within sterile pharmaceutical manufacturing; experience with Positron Emission Tomography (PET) or radiopharmaceutical products strongly preferred.
• Demonstrated experience overseeing and managing third-party Contract Manufacturing Organizations (CMOs), including performance monitoring and issue resolution.
• Comprehensive understanding of Quality Management System (QMS) principles, quality oversight, deviation management, CAPA, change control, and risk management practices.
• Prior working knowledge of U.S. regulatory requirements, including 21 CFR Parts 211 and 212, is highly desirable.
• Proven ability to collect, consolidate, analyze, and interpret operational and quality performance data to generate meaningful dashboards and management reports.
• Willingness to travel domestically up to ~30%, with occasional international travel as needed.

Soft Skills – Company Values & Behaviors

• Excellent investigation, problem solving, and report writing skills.
• Excellent written and verbal communication skills, negotiation, collaboration, and interpersonal skills with ability to work effectively with others at all levels of the organization.
• Ability to influence and build relationships/earn credibility quickly across broad global constituencies with competing priorities.

Salary: $140,000 - 170,000 Annually

Blue Earth Diagnostics offers a highly competitive salary for high-caliber candidates. We also offer a comprehensive benefits package including a complete healthcare plan, 401k with matching, work/life harmony, and generous paid holidays.

Blue Earth Diagnostics is an equal opportunity employer. All qualified applicants will receive consideration for employment without discrimination on grounds of disability, age, race, color, religion, sex, national origin or any other characteristic protected by law.