Sr. Clinical Quality Specialist
Norwood, MA 02062
Reference Number: 2448
Location: Westwood, MA
Growing Pharmaceutical Company is searching for a dynamic Sr. Clinical Quality Specialist to partner with the clinical team while overseeing quality and audit for both internal sites as well as external vendors. This role will wear a lot of hats and we are seeking someone that will thrive in a fast-paced small team environment.
- Oversee the scheduling and management of all Site, Vendor and Internal Audits
- Execute regular quality reviews and document audits within: Clinical Quality Plans, Clinical Study Reports, and Development Safety Update Reports
- Oversight and review of Quality System documents: CAPA, Deviations, Etc.
- Provide vendor assessments, audit reports, vendor questionnaires and trending of observations across study
- Development, revision, and review of SOPs, Standard Operating Procedures
- Conduct Risk Assessments and Management of Risk Remediation Plans
- Mentoring of staff / teammates as this will lead to future leadership opportunities
$80,000 - $100, 000 Base Salary with bonus, incentives, benefits and more!
(you must have ALL for consideration):
- MUST have Audit experience – either with external vendors or internal company sites
- MUST have 3+ years of experience in Clinical Quality Assurance
- MUST have expertise in ICH/GCP guidelines
- MUST have the ability to travel up to 20%
Research & Recruitment Specialist
Paula joined the Morisey-Dart Group in August of 2017. She is the firm’s research and recruitment specialist for the medical device and precision machining/manufacturing teams. She is responsible for sourcing and recruiting, lead generation, internet research and various other responsibilities within both the medical device and precision machining industries.
With 25 years at Xerox Corporation in New York, Paula had a prosperous and noteworthy career where she excelled during her tenure. She brings her vast knowledge and expertise in procurement, supply chain, contract administration and project management to the firm. She is a creative and natural problem-solver with proven success in developing and implementing new procedures and processes as well as integrating newly acquired subsidiaries.
Now, she’s using her expertise to build a network of solid relationships in the medical device and precision machining industries that help hiring managers find the top talent they need to improve their organizations.
Paula is Lean Six Sigma certified (Green Belt), has a Master of Science in business management and a Bachelor of Science in education.