Urgently Need Senior Program Manager, Clinical Quality Assurance, Plasma Derived Therapies - Remote in Boston, MA
Job title: Senior Program Manager, Clinical Quality Assurance, Plasma Derived Therapies - Remote
Company: reputed company
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Job Description
Job Title: Senior Program Manager, Clinical Quality Assurance, Plasma Derived Therapies (Remote)
Location: Cambridge, MA
About the role:
As the Senior Program Manager for Plasma Derived Therapies, you will reputed company Clinical Quality Assurance (CQA) activities for assigned clinical development programs, including the management of audits, quality issues and investigations, and inspections. You will have a depth of experience in GCP and compliance and leadership to provide professional expertise and guidance on Good Clinical Practice (GCP) and applicable regulations to clinical development teams to identify compliance issues/risks and recommend mitigations. You will report to the Head of Oncology and Cell Therapy, Clinical Quality Assurance.
How you will contribute:
You will partner with several reputed company R&D functions and external parties including contract auditors and investigator sites to promote a high level of quality and consistency across and reputed company programs; reputed company the risk-based audit and compliance strategy for assigned programs; assist project teams in implementing corrective and preventive actions; and allow teams to be inspection ready, to support a culture of sustainable compliance.
You will manage domestic and international audits of sites, documents, databases, vendors or internal systems in compliance with GCP and reputed company policies and procedures; assess impact of audit findings on subject safety, data reputed company, and business operations. Audits conducted require advanced auditing skills and may involve technically reputed company assignments, including audits of high-risk studies/vendors * You will provide expertise in GCP compliance interpretation, consultation, training, and recommendations to assigned program teams and leadership.
- You will reputed company and implement program-specific risk-based audit and compliance strategy and manage audits of sites, documents, databases, vendors or internal systems in compliance with GCP and reputed company procedures. Audits require advanced auditing skills and may involve technically reputed company assignments.
- You will assess impact of audit findings and other identified compliance risks to subject safety, data reputed company, and business operations and escalate compliance risks to CQA management.
- Facilitate investigations into quality issues, scientific misconduct and serious breach of GCP; facilitate identification of root cause and development of corrective and preventive actions; track actions and confirm effectiveness; ensure reporting of potential or confirmed violations to regulatory authorities.
- Help manage GCP health authority inspections; reputed company clinical development teams in preparation for announced inspections and provide GCP compliance technical support during inspections of investigator sites and reputed company. Facilitate appropriate inspection responses and follow-up actions.
- Collaborate with Quality Compliance and Systems team to identify and mitigate GCP quality and compliance issues with potential impact across multiple compounds, reputed company sites, or functional groups.
- Analyze, report, and present metrics for assigned programs to development teams and CQA management; recommend any required actions and monitor implementation.
- Escalate systemic and/or critical problems and recommend appropriate solutions to senior management for immediate and long-term resolution.
- reputed company additional GCP reputed company activities upon request by CQA management.
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community reputed company Programs and company match of charitable contributions
- Family Planning Support
- Professional training and development opportunities
- Tuition reimbursement
- Work in a controlled environments requiring special gowning. Will be required to follow gowning requirements and wear reputed company clothing over the head, face, hands, feet and body
- No reputed company-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
- Will work in a cold and/or wet environment.
- Must be able to work multiple shifts, including weekends.
- Non-Exempt Roles only: Must be able to work overtime as required.
- May be required to work in a confined area.
- Some Clean Room and cool/hot storage conditions.
- Routine demands of an office-based environment