Manager GMP Quality Assurance

Radius Health is a global biopharmaceutical company dedicated to transforming the future for patient populations in bone health and related therapeutic areas. Our team works relentlessly to improve the lives of our patients, their caregivers, our communities, our partners, and each other. We live by our corporate values, and every employee has an unwavering commitment to contributing to our positive culture.  We are currently recruiting for a Manager GMP Quality Assurance.

 Job Summary:

The Manager, GMP Quality Assurance will be responsible for executing, monitoring, and improving Quality Assurance processes and procedures for drug product manufacturing. Specific responsibilities include performing batch record review and disposition, reviewing and approving deviation investigations, investigating or reviewing product quality complaints, and supporting change management activities.

Essential Responsibilities: 

• Ensure GMP compliance of product development, validation and commercial manufacturing
• Review master and executed batch records and QC test data for disposition of commercial and investigational products
• Perform, review, and/or approve GMP records as assigned:
  • Investigation of product quality complaints (PQCs)
  • Investigations of GMP manufacturing or lab issues and out of specification results. Ensure adequate root cause analysis as well as identification and implementation of effective CAPA
  • Change Control documentation for changes related commercial manufacturing, testing and facilities
• Provide oversight for GMP QA owned quality systems by inputting to quality metrics and calculating monthly quality metrics for periodic review meetings
• Lead the development and improvement of GMP QA processes and procedures
• Support annual product quality review report
• Support regulatory inspections, and perform internal audits
• Perform audits of vendors including contract manufacturers and test labs
• Identify and escalate compliance issues to Senior Management

Experience and Qualifications: 

• Solid understanding of pharmaceutical and medical device quality assurance principles including global cGMP requirements, 21CFR Part 210 and 211, 21CFR Part 820, EU Volume 4, and other relevant regulations
• Bachelor’s degree in Biology/Chemistry or science related
• 5 years of relevant GMP experience in biopharmaceutical supplier or contract QA with 3 years of experience in a laboratory or manufacturing operations.
• Strong administrative skills including Microsoft Office Suite (Word, Excel, PowerPoint)
• Experience collaborating with cross functional teams
• Experience in management and use of electronic quality management systems preferred
• Ability to travel up to 10% preferred

Work Environment

The work is performed primarily in a remote office environment with occasional required in person office work, meetings, and/or travel. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this position, the employee is regularly required to use hands to type, handle paperwork and sort, file or manipulate documents. The employee is occasionally required to stand and walk. The employee is required to utilize audio visual programs for frequent meetings and discussions with fellow employees, vendors, outside agencies and/or customers. The employee may lift and/or move up to 10 pounds occasionally.

Company Information

Radius is a global biopharmaceutical company dedicated to transforming the future for underserved, global patient populations in bone health and related areas. Radius’ lead product, TYMLOS® (abaloparatide) injection, was approved by the U.S. Food and Drug Administration in April 2017 for the treatment of postmenopausal women with osteoporosis at high risk for fracture, and in December 2022 to increase bone density in men with osteoporosis at high risk for fracture. Radius also has an exclusive licensing and distribution agreement for the U.S. rights to BINOSTO® (alendronate sodium) effervescent tablet for oral solution, expanding our presence in bone health.

Equal Opportunity Employer Statement

Radius Health, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, disability, genetics, or protected veteran status. In addition to federal law requirements, Radius Health, Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

At Radius Health, Inc. we have a commitment to our culture and to our employees’ well-being and work-life balance. We support this mission by offering a compensation package with medical, dental and vision benefits.  We also provide parental leave, a 401K match and a generous time off plan including two company shutdowns; the week of July 4^th and the last week in December. We are proud to provide a competitive salary range for the Manager GMP Quality Assurance role, which is $125,000 – 145,000.

Salary : $125,000 - $145,000