Manager, Quality Compliance at SHINE SPECT USA LLC – North Billerica, Massachusetts

SHINE SPECT is seeking a Manager, Quality Compliance as a key leadership role within the Quality Assurance organization, responsible for ensuring that the site maintains a robust state of regulatory compliance and perpetual inspection readiness. The Manager, Quality Compliance position oversees a team that manages internal audits, regulatory inspections, customer and partner audits, and quality programs critical to GMP compliance for radiopharmaceutical products.

The Manager, Quality Compliance drives compliance initiatives, leads the implementation of quality improvements across the facility, monitors regulatory changes, and ensures effective execution of core quality system programs. This role also plays a central part in developing, reinforcing, and sustaining a strong, proactive quality culture across the site. This position reports directly to the Head of Quality Assurance and includes direct reports.

This position is based in Massachusetts and requires presence on-site five days per week.

The base salary range for this position is $120,000-$160,000 per year plus a comprehensive compensation package. Our salary ranges are determined by role, level, and location.

Duties and Responsibilities:

Inspection Readiness & Audits:

• Lead and maintain a site-wide inspection readiness program for regulatory, customer, and partner inspections.
• Oversee planning, execution, and follow-up of internal audits and external inspections, including SME and documentation preparation.
• Serve as primary inspection liaison, managing document requests, communication flow, and inspection room activities.
• Ensure timely development, implementation, and closure of CAPAs related to audit and inspection findings.

Compliance Systems Oversight:

• Oversee intake, investigation, trending, and closure of product complaints.
• Manage Field Alert Reports (FARs), recalls, and associated regulatory assessments.
• Lead preparation and review of Annual Product Quality Reviews (APQRs), ensuring effective trend analysis and improvement actions.
• Manage the Quality Management Review (QMR) process and ensure accurate reporting of site quality metrics.

Risk Management Program Leadership:

• Own and maintain the site risk register, ensuring risks are documented, assessed, prioritized, and updated routinely.
• Lead the site risk management program, partnering with cross functional teams to identify risks, plan and monitor mitigations, conduct periodic reassessments, and ensure alignment with corporate and regulatory Quality Risk Management (QRM) expectations, including ICH Q9.
• Promote a risk based approach to compliance, improvement, and decision making across the site.

Regulatory Intelligence & Continuous Improvement:

• Monitor regulatory updates, industry trends, and guidance changes relevant to radiopharmaceutical operations.
• Conduct gap assessments and drive implementation of required changes to procedures, policies, or systems.

Leadership & Team Management:

• Lead, mentor, and develop the Quality Compliance team to ensure strong performance and technical capability.
• Set priorities, establish clear expectations, and ensure appropriate training and competency.
• oster a collaborative, solutions oriented environment focused on continuous improvement.

Education & Experience

• Bachelor’s degree in a scientific or technical field preferred.
• 7+ years of experience in GMP Quality Assurance, Quality Compliance, or related functions within the pharmaceutical, biotechnology, or radiopharmaceutical industry.
• Demonstrated experience with regulatory inspections and quality compliance programs.
• Prior people management experience required preferred

Skills & Competencies

• Strong understanding of GMP regulations, including but not limited to 21 CFR Parts 210/211/212 and ICH guidelines.
• Proven experience with quality systems including audits, CAPA, complaints, recalls, APQR, and risk management.
• Strong analytical, organizational, and communication skills with the ability to influence at all levels.
• Ability to lead under pressure and maintain composure during inspections.
• Demonstrated ability to promote and sustain a strong quality culture.

SHINE values diversity in all its forms as a critical component of innovation, which is fundamental to our success. Every member of the SHINE community benefits from the talents and experiences of our peers, from the mutual respect we exercise, and from the responsibility we take for our actions.

SHINE Technologies is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.

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