Quality Assurance Manager, RWE Clinical Trials - Remote
Job Description
Job Summary...
The Quality Assurance Manager is responsible for the operations and maintenance of the Quality Management System (QMS) under oversight of the Sr. Director of Quality Assurance. The Quality Assurance function serves to ensure compliance with the US FDA requirements as well as internal quality systems requirements. The Quality Assurance function also has oversight of internal and sponsor audits as well as regulatory inspections, compliance and regulatory support initiatives. This position plays a crucial role in Clinical Trials program wide culture of quality.
Job Responsibilities:
Accountable for daily operations to maintain Quality standards and project timelines.
Demonstrate proficiency in formal quality management systems (QMS) deployment.
Lead QMS initiatives (e.g., Vendor Management Process, CAPA)
Manage Clinical Trials Standard Operating Procedure development, review and maintenance.
Maintain an open line of communication with the stakeholders or project deliverables.
Identify and escalate any critical or major findings or trends to the Sr. Director of Quality Assurance.
Provide guidance to staff in resolving findings and implementing processes, including root case analysis, implementation, and evaluation of CAPA plans.
Work closely with leadership to close identified gaps and ensure continuous process improvement in collaboration with the broader Quality Management function (i.e., Quality Control, Quality
Assurance, and Compliance)
Develop internal and external audits/inspections plans and conduct audits.
Ensure conduct of initial and ongoing study risk assessments and the development of strategies for approaching identified risks.
Contribute to development and implementation of an integrated Quality Management Plan for each study, as needed.
Independently review reports and documentation generated by the sponsor/CRO for each ensure all findings are resolved.
Support the Sr. Director of Quality Assurance with implementation of a comprehensive staff training program, including content delivery and documentation compliance with all required training.
About Walgreens and WBA
Walgreens (www.walgreens.com) is included in the U.S. Retail Pharmacy and U.S. Healthcare segments of Walgreens Boots Alliance, Inc. (Nasdaq: WBA), an integrated healthcare, pharmacy and retail leader with a 170 year heritage of caring for communities. WBA's purpose is to create more joyful lives through better health. Operating nearly 9,000 retail locations across America, Puerto Rico and the U.S. Virgin Islands, Walgreens is proud to be a neighborhood health destination serving nearly 10 million customers each day. Walgreens pharmacists play a critical role in the U.S. healthcare system by providing a wide range of pharmacy and healthcare services, including those that drive equitable access to care for the nation's medically underserved populations. To best meet the needs of customers and patients, Walgreens offers a true omnichannel experience, with fully integrated physical and digital platforms supported by the latest technology to deliver high-quality products and services in communities nationwide.
The actual salary an employee can expect to receive, plus bonus pursuant to the terms of any bonus plan if applicable, will depend on experience, seniority, geographic location, and other factors permitted by law. To review benefits, please visit jobs.walgreens.com/benefits.
"An Equal Opportunity Employer, including disability/veterans".
External Basic Qualifications
Bachelor's degree and 4 years of experience in Pharma/Clinical Quality Management OR High School/GED and 7 years of experience in Pharma/Clinical Quality Management.
Deep understanding of the drug/device development process including new clinical trials models.
Exceptional working knowledge of ICH GCP, US CFR, and HIPAA regulations.
Experience working independently and making informed decisions related to clinical trial quality.
Experience overseeing multiple clinical trials concurrently, while maintaining attention to detail.
Experience prioritizing tasks and resources, meeting deadlines, and being adaptable to changing priorities.
At least 2 years of experience contributing to financial decisions in
the workplace.
At least 2 years of direct leadership, indirect leadership and/or cross functional team leadership.
Willing to travel up to/at least 25% of the time for business purposes (within state and out of state)
Preferred Qualifications
Quality Management System and continuous improvement experience.
Decentralized/hybrid clinical trials experience.
Expertise of modern clinical trial site technologies (e.g., eReg, eSource, eConsent).
Tech-savvy with the experience applying new systems to everyday tasks
Apply Now
For more such jobs please click here!
Job Summary...
The Quality Assurance Manager is responsible for the operations and maintenance of the Quality Management System (QMS) under oversight of the Sr. Director of Quality Assurance. The Quality Assurance function serves to ensure compliance with the US FDA requirements as well as internal quality systems requirements. The Quality Assurance function also has oversight of internal and sponsor audits as well as regulatory inspections, compliance and regulatory support initiatives. This position plays a crucial role in Clinical Trials program wide culture of quality.
Job Responsibilities:
Accountable for daily operations to maintain Quality standards and project timelines.
Demonstrate proficiency in formal quality management systems (QMS) deployment.
Lead QMS initiatives (e.g., Vendor Management Process, CAPA)
Manage Clinical Trials Standard Operating Procedure development, review and maintenance.
Maintain an open line of communication with the stakeholders or project deliverables.
Identify and escalate any critical or major findings or trends to the Sr. Director of Quality Assurance.
Provide guidance to staff in resolving findings and implementing processes, including root case analysis, implementation, and evaluation of CAPA plans.
Work closely with leadership to close identified gaps and ensure continuous process improvement in collaboration with the broader Quality Management function (i.e., Quality Control, Quality
Assurance, and Compliance)
Develop internal and external audits/inspections plans and conduct audits.
Ensure conduct of initial and ongoing study risk assessments and the development of strategies for approaching identified risks.
Contribute to development and implementation of an integrated Quality Management Plan for each study, as needed.
Independently review reports and documentation generated by the sponsor/CRO for each ensure all findings are resolved.
Support the Sr. Director of Quality Assurance with implementation of a comprehensive staff training program, including content delivery and documentation compliance with all required training.
About Walgreens and WBA
Walgreens (www.walgreens.com) is included in the U.S. Retail Pharmacy and U.S. Healthcare segments of Walgreens Boots Alliance, Inc. (Nasdaq: WBA), an integrated healthcare, pharmacy and retail leader with a 170 year heritage of caring for communities. WBA's purpose is to create more joyful lives through better health. Operating nearly 9,000 retail locations across America, Puerto Rico and the U.S. Virgin Islands, Walgreens is proud to be a neighborhood health destination serving nearly 10 million customers each day. Walgreens pharmacists play a critical role in the U.S. healthcare system by providing a wide range of pharmacy and healthcare services, including those that drive equitable access to care for the nation's medically underserved populations. To best meet the needs of customers and patients, Walgreens offers a true omnichannel experience, with fully integrated physical and digital platforms supported by the latest technology to deliver high-quality products and services in communities nationwide.
The actual salary an employee can expect to receive, plus bonus pursuant to the terms of any bonus plan if applicable, will depend on experience, seniority, geographic location, and other factors permitted by law. To review benefits, please visit jobs.walgreens.com/benefits.
"An Equal Opportunity Employer, including disability/veterans".
External Basic Qualifications
Bachelor's degree and 4 years of experience in Pharma/Clinical Quality Management OR High School/GED and 7 years of experience in Pharma/Clinical Quality Management.
Deep understanding of the drug/device development process including new clinical trials models.
Exceptional working knowledge of ICH GCP, US CFR, and HIPAA regulations.
Experience working independently and making informed decisions related to clinical trial quality.
Experience overseeing multiple clinical trials concurrently, while maintaining attention to detail.
Experience prioritizing tasks and resources, meeting deadlines, and being adaptable to changing priorities.
At least 2 years of experience contributing to financial decisions in
the workplace.
At least 2 years of direct leadership, indirect leadership and/or cross functional team leadership.
Willing to travel up to/at least 25% of the time for business purposes (within state and out of state)
Preferred Qualifications
Quality Management System and continuous improvement experience.
Decentralized/hybrid clinical trials experience.
Expertise of modern clinical trial site technologies (e.g., eReg, eSource, eConsent).
Tech-savvy with the experience applying new systems to everyday tasks
Apply Now
For more such jobs please click here!