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Blue Earth Diagnostics, Inc. (U.S.) · 14 hours ago

Senior Manager Quality Operations

Needham, MA

Full-time

Hybrid

Senior Level

$140K/yr - $170K/yr

5+ years exp

Blue Earth Diagnostics, Inc. is seeking a Senior Manager Quality Operations to manage the quality operations of their U.S. based third-party Contract Manufacturing Organization network. This role involves overseeing manufacturing performance, ensuring compliance with regulatory requirements, and driving continuous performance improvement.

Pharmaceuticals

Responsibilities

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

Qualification

Quality AssuranceQuality Management System (QMS)Regulatory complianceContract Manufacturing Organizations (CMOs)Positron Emission Tomography (PET)Data analysisProblem solvingCommunication skillsInterpersonal skillsNegotiation skills

Required

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

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

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

Benefits

A complete healthcare plan

401k with matching

Work/life harmony

Generous paid holidays

Company

Blue Earth Diagnostics, Inc. (U.S.)

Blue Earth Diagnostics is an established molecular imaging company focused on providing innovative, well-differentiated diagnostics solutions, informing patient management, and driving future therapies in cancer.

Founded in 2014

Monroe Township, New Jersey, US

51-200 employees