Senior Manager GMP Quality Assurance

Radius Health

Radius Health is an equal opportunity employer. EEO/Disabled Individuals/Veterans. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to . Click here to navigate to the "EEO is the Law" poster. Click here to navigate Radius Health's Pay Transparency Policy.

Position Title: Senior Manager GMP Quality Assurance

Job Category: Quality

Req ID: SENIO002380

Schedule: Full Time

Posted:Apr 9, 2025

Job Details
Description

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 Senior Manager GMP Quality Assurance.

Job Summary:

The Senior Manager, GMP Quality Assurance will collaborate with internal teams and external partners to ensure GMP compliance of drug and drug/device combination products throughout development and commercial manufacturing. This role will manage key Quality Assurance activities including batch disposition, deviation and CAPA management, complaint investigations, and change management. Additionally, the Senior Manager will partner with Quality Assurance colleagues to monitor and drive continuous improvement of these processes.

Essential Responsibilities:
Partner with internal functions and contract manufacturers to ensure compliance of development, validation, and commercial manufacturing activitiesReview and approve specifications, master batch records, test methods, and stability dataReview executed batch records and QC test data for disposition of commercial and investigational productsProvide oversight for validation activities conducted at contract manufacturing and testing organizationsLead, review, and/or approve investigations into GMP-related deviations and out-of-specification results. Ensure thorough root cause analysis and the implementation of effective CAPAReview and support product quality complaint investigationsPrepare and review change control documentation for changes related to commercial manufacturing and testingMaintain oversight of Design History File, ensuring changes and routine reviews are accurately documentedOversee risk management activities and lead cross functional team to develop and maintain FMEAsLead the development and improvement of GMP QA processes and proceduresContribute to development of quality metrics and calculate monthly metricsSupport preparation of annual product quality review reportSupport regulatory inspections, and perform internal auditsPerform audits of contract manufacturers and test labsIdentify 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 regulationsExperience preferred in execution of key elements of Design Control (design reviews, design verification, management of design history file) and Risk Analysis processes (design, process and use FMEAs.)Bachelor's degree in biology/chemistry or science related7 + 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 teamsExperience in management and use of electronic quality management systems preferredAbility 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 4th and the last week in December. We are proud to provide a competitive salary range for the Senior Manager GMP Quality Assurance role, which is $140,000 - 160,000.

EOE:
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Equal employment opportunity, including veterans and individuals with disabilities.

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