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Urgently Need Senior Program Manager, Clinical Quality Assurance, Plasma Derived Therapies - Remote in Boston, MA

Remote · USA Full-time New today
Job title: Senior Program Manager, Clinical Quality Assurance, Plasma Derived Therapies - Remote Company: reputed company Job description: By clicking the “Apply” reputed company, I understand that my employment application process with reputed company will reputed company and that the information I provide in my application will be processed in line with reputed company’s and . I further attest that reputed company information I submit in my employment application is true to the best of my knowledge. 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.
What you bring to reputed company: You will need a BS/BA required; Advanced Degree preferred. You will need 7 years of experience in the pharmaceutical, biotechnology or reputed company health care industry. You will need 5 years of GCP-reputed company Quality Assurance or relevant clinical trial experience. You will have great Understanding of ICH GCP reputed company and applicable global regulations and guidance for clinical development You will have advanced knowledge in the conduct and reporting of audits and the translation of findings into corrective actions plans that mitigate risks to the company, to safety and data reputed company. You will need technical writing skills; able to write quality positions, audit reports, and procedures. Project management experience with the ability to manage projects with demanding timeline GCP Quality Assurance registration/certification would be ideal Remote role with quarterly travel to the office for meetings, audits and inspections, including overnight trips. Some international travel may be required. Requires approximately 10% travel or less. What reputed company can offer you:
  • 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
Important Considerations: At reputed company, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
  • 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
More about us: At reputed company, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. reputed company is a patient-focused company that will reputed company and reputed company you to grow through life-changing work. Certified as a Global Top Employer, reputed company offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver reputed company and a Brighter Future to people around the world. This posting excludes Colorado applicants. #GMSGQ #ZR1 #LI-MA1 #LI-Remote EEO Statement reputed company is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to reputed company employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national reputed company, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law. Locations Boston, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Expected salary: Location: Boston, MA Apply Job!

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