Manufacturing Quality Manager

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Job Type

Full-time

Description

SHINE Technologies is seeking a Manufacturing Quality Manager who will lead a team of manufacturing quality staff responsible for the execution of the SHINE GMP compliance strategy conducted in accordance with applicable laws, regulations, and guidelines. As the GMP compliance subject matter expert within the Diagnostics Division, the Manufacturing Quality Manager ensures the maintenance of a robust and inspection-ready GMP quality management system, while integrating the system into the existing nuclear quality management system as appropriate.

The base salary range for this position is $125,000 - $150,000 per year plus a comprehensive compensation package. Our salary ranges are determined by role, level, and location.

Duties And Responsibilities

Specific duties and responsibilities include, but are not limited to:

• Oversee the development, implementation, and maintenance of the GMP quality management system in accordance with applicable regulatory requirements and guidelines, and the integration of the system within the existing framework of the nuclear quality management system.
• Oversee the development of Drug Master Files.
• Oversee the development of the Master Validation Plan.
• Ensure that GMP work within the Diagnostics division is done in compliance with applicable laws, regulations, guidelines, and SOPs.
• Proactively identify potential quality risks and establish mitigation strategies.
• Monitor and implement quality improvement efforts for greater efficiency and compliance with applicable GMP regulations
• Develop and manage quality agreements with SHINE customers.
• Interface with SHINE customers to ensure requirements of the quality agreements are understood and met.
• Lead the participation, coordination, and responses to internal and external audits and inspections.
• Plan the scope of the manufacturing quality work and establish priorities.
• Advise the organization on manufacturing quality-related issues.
• Develop and manage the departmental budget.
• Perform other duties as assigned.
  
  

Requirements

• Bachelor’s degree in chemistry, biology, radiochemistry, or other related scientific discipline, or equivalent experience.
• At least 5 years of GMP-related experience in biopharmaceutical/pharmaceutical or related industry with direct Quality experience, or equivalent combination of education and experience, with experience in radiopharmaceuticals preferred..
• Demonstrated knowledge of Title 21 of the Code of Federal Regulations (CFR), with an emphasis on cGMP.
• Demonstrated knowledge of applicable regulatory guidelines.
• Experience in designing and implementing quality management systems.
• Ability to communicate effectively with all levels within the organization, as well as interface with regulators, contractors, and suppliers.
  
  

Working Conditions And Physical Effort

• Requires frequent leaning, bending, stooping, crouching, grasping, and reaching above the shoulders and below the knees.
• Moderate physical activity. Requires handling of average-weight objects up to 40 pounds or standing and/or walking for more than four (4) hours per day.
• Fine motor coordination and strong depth perception is beneficial.
• Work involves moderate exposure to unusual elements, such as extreme temperatures, dirt, dust, fumes, smoke, unpleasant odors, and/or loud noises.
• Work environment involves some exposure to hazards or physical risks, which require following basic safety precautions.
  
  

Eligibility for employment is conditioned on the applicant’s ability to qualify for access to information subject to U.S. Export Controls. Additionally, applicant’s eligibility may be conditioned based upon meeting the Nuclear Regulatory Commission requirements for access to Safeguards Information, which typically requires a pre-employment drug screen, fingerprinting and criminal background check.

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.