Position:Quality Assurance Manager
Location:Boston, MA (Hybrid - 3 days onsite)
Length:12+ months
Job Description:
Our client is seeking a Quality Assurance Manager to join its Quality Assurance team. The successful candidate will be responsible for ensuring adherence to Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) standards across global operations. This role involves oversight of third-party partners, support of internal stakeholders, management of quality systems, and preparation for external inspections. The ideal candidate will bring a strong background in quality assurance, with an emphasis on distribution compliance, cross-functional collaboration, and continuous improvement in a dynamic, regulated environment.
Essential Duties and Responsibilities (but not limited to):
- Manage and improve Quality Management Systems (QMS) in alignment with GDP requirements.
- Monitor and update distribution licenses and ensure regulatory compliance.
- Provide quality support for product recalls, mock recall exercises, and market-related activities.
- Review and approve change control documentation, ensuring alignment with compliance standards.
- Contribute to quality performance reviews by tracking metrics, identifying risks, and recommending improvements.
- Participate in the development of quality frameworks for new markets and operational expansions.
- Support audit readiness and regulatory inspections, including preparation and post-inspection follow-up.
- Oversee investigations and resolutions of deviations, including time-sensitive issues.
- Track corrective and preventive actions (CAPAs), ensuring implementation and effectiveness.
- Coordinate with complaint handling teams to ensure timely and effective issue resolution.
- Ensure qualification of third parties involved in distribution, including suppliers and subcontractors.
- Plan and conduct internal audits and follow up on implementation of corrective actions.
- Review product returns and make final quality decisions on their disposition.
- Ensure compliance with applicable local and international regulatory requirements.
- Draft, review, and approve SOPs and quality-related documentation.
Qualifications:
- Bachelor's degree in a scientific or related discipline (or equivalent experience).
- At least 5 years of experience in quality assurance, ideally within a regulated healthcare, pharmaceutical, or life sciences setting.
- Solid knowledge of GDP and GMP principles.
- Ability to collaborate and influence cross-functional teams effectively.
- Experience with audits and regulatory inspections is a strong advantage.
- Excellent written and verbal communication skills.
- Comfortable using common business software tools (i.e., MS Word, Excel, and PowerPoint).
POST-OFFER BACKGROUND CHECK IS REQUIRED. Digital Prospectors is an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law. Digital Prospectors affirms the right of all individuals to equal opportunity and prohibits any form of discrimination or harassment.
Come see why DPC has achieved:
- 4.9/5 Star Glassdoor rating and the only staffing company (< 1000 employees) to be voted in the national Top 10 'Employee's Choice - Best Places to Work' by Glassdoor.
- Voted 'Best Staffing Firm to Temp/Contract For' seven times by Staffing Industry Analysts as well as a 'Best Company to Work For' by Forbes, Fortune and Inc. magazine.
As you are applying, please join us in fostering diversity, equity, and inclusion by completing the Invitation to Self-Identify form today!
www.LoveYourJob.com
|
Digital Prospectors
Apr 25, 2025