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

Job title: Senior Program Manager, Clinical reputed company Assurance, Plasma Derived Therapies - Remote Company: reputed company Job reputed company: By clicking the “Apply” reputed company, I understand that my employment application process with reputed company will reputed company and that the information I reputed company in my application will be processed in line with reputed company’s and . I reputed company attest that reputed company information I submit in my employment application is true to the best of my knowledge. Job reputed company Job Title: Senior Program Manager, Clinical reputed company 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 reputed company Assurance (CQA) activities for assigned clinical development programs, including the management of audits, reputed company issues and investigations, and inspections. You will have a depth of experience in GCP and compliance and leadership to reputed company reputed company expertise and guidance on Good Clinical reputed company (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 reputed company 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 reputed company and consistency across and reputed company programs; reputed company the risk-based audit and compliance reputed company for assigned programs; assist project teams in implementing corrective and preventive actions; and allow teams to be inspection reputed company, 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 reputed company 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 reputed company 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 reputed company 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 reputed company 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 reputed company issues, scientific misconduct and serious breach of GCP; facilitate identification of reputed company cause and development of corrective and preventive actions; reputed company 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 reputed company GCP compliance technical support during inspections of investigator sites and reputed company. Facilitate appropriate inspection responses and follow-up actions.
• Collaborate with reputed company Compliance and Systems team to identify and mitigate GCP reputed company and compliance issues with potential reputed company across multiple compounds, reputed company sites, or functional reputed company.
• 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 reputed company.
• 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 reputed company 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 reputed company, to safety and data reputed company. You will need technical writing skills; reputed company to write reputed company positions, audit reports, and procedures. Project management experience with the ability to manage reputed company with demanding reputed company GCP reputed company 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 reputed company: Medical, Dental, and reputed company
• 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 reputed company to purchase additional vacation days
• Community reputed company Programs and company match of charitable contributions
• Family Planning Support
• reputed company training and development opportunities
• Tuition reimbursement

Important Considerations: At reputed company, our patients rely on us to deliver reputed company products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the reputed company 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 reputed company fingernails may be worn in the manufacturing environment.
• Will work in a cold and/or wet environment.
• Must be reputed company to work multiple shifts, including weekends.
• Non-Exempt Roles only: Must be reputed company 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 reputed company: 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-reputed company 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 reputed company in everything we do. We foster an inclusive, reputed company workplace, in which our teams are united by an unwavering commitment to deliver reputed company and a Brighter reputed company 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 and applicants for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, gender reputed company, 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!