Inspection Readiness Manager
2 weeks ago
Position: Inspection Readiness Manager
Location: Boston, MA (Hybrid – 3 days onsite)
Length: 6+ months
Job Description:
Our client is seeking a highly motivated and experienced Inspection Readiness Manager to join a dynamic team. This role will support critical GMP and GDP quality activities, ensuring the organization is consistently prepared for inspections and audits. The ideal candidate will have expertise in quality assurance and compliance, a strong background in project management, and a proven ability to collaborate across internal and external teams to maintain inspection readiness.
Essential Duties and Responsibilities (but not limited to):
Develop and manage comprehensive inspection readiness strategies, ensuring alignment with regulatory requirements and company goals.
Collaborate with external partners and internal teams to assess risks and implement mitigation plans for inspections.
Oversee and track progress of readiness activities, ensuring timely execution and addressing any gaps.
Work with various internal departments to align inspection preparations and ensure all necessary documentation and evidence are in place.
Provide support during inspections, including scenario simulations and coordination across teams to maintain smooth execution.
Identify opportunities for process improvement and contribute to enhancing inspection readiness protocols.
Assist in the development and revision of relevant procedures and documentation to ensure ongoing regulatory compliance.
Monitor inspection readiness tools and maintain critical systems to ensure continuous preparation for future inspections.
Manage multiple projects, ensuring efficient execution through clear planning, tracking, and reporting of key milestones.
Support the management of inspection schedules, forecasting, and readiness tracking tools.
Qualifications:
Bachelor’s degree in a scientific or allied health field with 5+ years of relevant experience or Master’s degree with 3-4 years of relevant experience.
Experience in GMP and GDP regulations, quality assurance, and compliance.
Proficient in project management and use of project management tools.
Strong communication skills with the ability to facilitate cross-functional collaboration.
Ability to navigate a fast-paced environment with a sense of urgency.
Strong organizational skills, capable of working independently and within cross-functional teams.
Critical thinking, problem-solving, and strategic planning capabilities.
Knowledge and experience in continuous process improvement.
Expertise in GMP and GDP regulations and risk management principles related to manufacturing and testing.
Proficient in root cause analysis and Corrective and Preventive Action (CAPA) methodologies.
Strong commitment to continuous quality improvement and regulatory compliance.
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.
Make this your next career move as one of our many long-term contractors or employees
Work as our full-time employee with full benefits (Medical, Dental, Vision, Life, STD, LTD, PTO, etc.) - OR - work as a W2 hourly contractor at a higher pay rate if you don't need the benefit package.
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