Job description
About USDM
USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to implementation and adoption, we have delivered thousands of GxP projects globally.
As part of the USDM team, you have the opportunity to work with cutting edge technologies through our many partnerships with companies like Microsoft, Google, Oracle, DocuSign, Box, and many more. From molecule to market, you will help connect technology, people, and data in new ways to generate real-time insights to improve business outcomes for USDM’s clients. Are you ready to make an impact and drive real digital transformation in life sciences?
Founded in Santa Barbara in 1999, USDM has grown to a progressive, global company with 300+ remote employees and offices throughout the US, Canada, and Germany.
Nature and Scope of Job
USDM is looking for an experienced Release QA Manager. The Release QA Manager will work closely with the Release team to support batch certification of products and cross-functionally to create and maintain standards for GXP compliance and will have a high degree of impact across the organization.
- Ensure products (DS and DP) are manufacturing in accordance with cGMPs, internal policies/procedures and applicable regulatory requirements and guidance.
- Oversee GDP related activities throughout the product supply chain, including transportation activities and customer qualification activities.
- Maintain thorough and up to date understanding of international regulatory requirements and guidance.
- Take actions necessary to maintain and extend technical and professional competence in support of batch release responsibilities and ensure thorough understanding of any products and processes prior to the batch certification and disposition.
- Understand and support review of investigations, root cause analysis and review and approval of major/critical deviations, complaints and change controls with process and product impact.
- Perform product impact assessments, including for temperature excursions.
- Support Quality Systems and Compliance on continuous improvement of the Quality Management System (QMS), support quality management review processes, annual product quality reviews, overall inspection readiness and state of control.
- Establish and maintain effective communication with clients to match internal and external expectations.
- Support product defects and recalls assessments if needed.
- Ensure quality systems, processes, specifications, and SOPs are designed to be appropriate for the development, manufacture, testing and timely release, and distribution of quality product, and consistent with the global quality strategy and meet all relevant regulatory requirements including local and international regulations and applicable standards and guidances.
- Support review of international regulatory filing information to ensure data integrity and regulatory compliance.
Qualifications
- Minimum of 5-10 years of international quality experience in the biotechnology or pharmaceutical industries.
Education & Certifications
- Bachelor’s degree; Advanced degree in natural or applied sciences (Pharmacy, chemistry, biotechnology, engineering) preferred.
Working Conditions
The working conditions described here are representative of those that must be met by an employee to successfully perform the essential responsibilities and functions of the job, and are not meant to be all inclusive. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential responsibilities and functions of the job.
Unless reasonable accommodations can be made, while performing this job the staff member shall:
- Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment.
- Operate other office productivity machinery, such as a calculator, scanner, or printer.
- Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations.
Equal Opportunity Statement
USDM Life Sciences 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 status as a protected veteran.
Disclaimer
This job description is intended to describe the general nature and the level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. USDM Life Sciences reserves the right to amend and change responsibilities to meet business and organizational needs as necessary.
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