QA Manager, Audit - Remote
Company Description
Medable's mission is to get effective therapies to patients faster. We provide an end-to-end, cloud-based platform with a flexible suite of tools that allows patients, healthcare providers, clinical research organizations and pharmaceutical sponsors to work together as a team in clinical trials. Our solutions enable more efficient clinical research, more effective healthcare delivery, and more accurate precision and predictive medicine. Our target audiences are patients, providers, principal investigators, and innovators who work in healthcare and life sciences.
Our vision is to accelerate the path to human discovery and medical cures. We are passionate about driving innovation and empowering consumers. We are proactive, collaborative, self-motivated learners, committed, bold and tenacious. We are dedicated to making this world a healthier place.
Job Description
Quality:
• Provide oversight to quality assurance activities:
• Internal/external audit program
• Quality Management Reviews (monthly/annual)
• Quality events (CAPA, complaints, non-conformances)
• Perform quality assurance activities, as needed.
• Other duties as assigned.
Audit:
• Independently leads the scheduling/planning, conducting, and reporting of assigned routine quality system audits and non-routine audits, to assure adherence to corporate policies, internal standards/requirements, and all documentation requirements are consistently adhered to comply with safety, quality, and applicable regulatory requirements. Non-routine audits may include Due Diligence, for-cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope.
• Collaborates with system owners to develop effective resolutions, such as CAPA, to address deficiencies noted during internal audits. Assists in the preparation and presentation of training materials as part of resolutions when applicable.
• Collaborates with external auditors in responding to observations and developing effective resolutions, as needed.
• Track all audit-related resolutions and ensure on-time closure
• Supports the development and mentorship of other auditors.
• Ensures the standard procedures, audit tools, and audit plans are fully understood and applied in audit activities.
• Analyzes and interprets data and identifies patterns and trends in data sets.
• Ensures timely and appropriate review & delivery of resolutions and actions arising from audits.
• Presents trending information logically and concisely, both verbally and in the writing of issued reports and/or during Quality Management Reviews.
• Maintains the confidentiality of company information.
• Other duties as assigned.
Inspections Support:
• Supports regulatory inspections in a lead or supporting role.
• Facilitates annual mock regulatory audit
• Conducts inspection readiness audits.
• Other duties as assigned.
Subject Matter Expert / Point of Contact:
• Maintains good communication and provides expertise and knowledge to less experienced auditors, Business Partners, and the core business sector on quality and compliance processes/procedures.
• Interprets and applies regulations/ policies to issues of moderate complexity, when required.
• Provides GCP Audit strategy support, especially on QA risk-based auditing approach (Audit plans).
• Provides coaching, useful feedback, and direction to teams.
• Other duties as assigned.
Qualifications
• 6+ years of experience in a quality role or a combination of education and experience.
• Experience working in a quality capacity (pharmaceutical or medical device preferred)
• Experience working in an ISO environment (preferred)
• Ability to handle sensitive information with the highest degree of integrity, discretion, and confidentiality.
• Ability to write, speak, and interact clearly and professionally.
• Analytical, problem-solving, and decision-making skills.
• Comfort working across teams in a fast-paced environment.
Education, Certification, Licenses:
• Six Sigma Green or Black Belt, preferred.
• ASQ Certified Auditor, preferred
#LI-REMOTE
#LI-AP1
Additional Information
Medable, Inc provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
U.S. employees and contractors, and International workers with travel to the U.S. must have a willingness and ability to provide proof of completed COVID-19 vaccination prior to start date. All strongly held beliefs, religious, medical, and other legally recognized exemptions regarding vaccination status will be considered.
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Medable's mission is to get effective therapies to patients faster. We provide an end-to-end, cloud-based platform with a flexible suite of tools that allows patients, healthcare providers, clinical research organizations and pharmaceutical sponsors to work together as a team in clinical trials. Our solutions enable more efficient clinical research, more effective healthcare delivery, and more accurate precision and predictive medicine. Our target audiences are patients, providers, principal investigators, and innovators who work in healthcare and life sciences.
Our vision is to accelerate the path to human discovery and medical cures. We are passionate about driving innovation and empowering consumers. We are proactive, collaborative, self-motivated learners, committed, bold and tenacious. We are dedicated to making this world a healthier place.
Job Description
Quality:
• Provide oversight to quality assurance activities:
• Internal/external audit program
• Quality Management Reviews (monthly/annual)
• Quality events (CAPA, complaints, non-conformances)
• Perform quality assurance activities, as needed.
• Other duties as assigned.
Audit:
• Independently leads the scheduling/planning, conducting, and reporting of assigned routine quality system audits and non-routine audits, to assure adherence to corporate policies, internal standards/requirements, and all documentation requirements are consistently adhered to comply with safety, quality, and applicable regulatory requirements. Non-routine audits may include Due Diligence, for-cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope.
• Collaborates with system owners to develop effective resolutions, such as CAPA, to address deficiencies noted during internal audits. Assists in the preparation and presentation of training materials as part of resolutions when applicable.
• Collaborates with external auditors in responding to observations and developing effective resolutions, as needed.
• Track all audit-related resolutions and ensure on-time closure
• Supports the development and mentorship of other auditors.
• Ensures the standard procedures, audit tools, and audit plans are fully understood and applied in audit activities.
• Analyzes and interprets data and identifies patterns and trends in data sets.
• Ensures timely and appropriate review & delivery of resolutions and actions arising from audits.
• Presents trending information logically and concisely, both verbally and in the writing of issued reports and/or during Quality Management Reviews.
• Maintains the confidentiality of company information.
• Other duties as assigned.
Inspections Support:
• Supports regulatory inspections in a lead or supporting role.
• Facilitates annual mock regulatory audit
• Conducts inspection readiness audits.
• Other duties as assigned.
Subject Matter Expert / Point of Contact:
• Maintains good communication and provides expertise and knowledge to less experienced auditors, Business Partners, and the core business sector on quality and compliance processes/procedures.
• Interprets and applies regulations/ policies to issues of moderate complexity, when required.
• Provides GCP Audit strategy support, especially on QA risk-based auditing approach (Audit plans).
• Provides coaching, useful feedback, and direction to teams.
• Other duties as assigned.
Qualifications
• 6+ years of experience in a quality role or a combination of education and experience.
• Experience working in a quality capacity (pharmaceutical or medical device preferred)
• Experience working in an ISO environment (preferred)
• Ability to handle sensitive information with the highest degree of integrity, discretion, and confidentiality.
• Ability to write, speak, and interact clearly and professionally.
• Analytical, problem-solving, and decision-making skills.
• Comfort working across teams in a fast-paced environment.
Education, Certification, Licenses:
• Six Sigma Green or Black Belt, preferred.
• ASQ Certified Auditor, preferred
#LI-REMOTE
#LI-AP1
Additional Information
Medable, Inc provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
U.S. employees and contractors, and International workers with travel to the U.S. must have a willingness and ability to provide proof of completed COVID-19 vaccination prior to start date. All strongly held beliefs, religious, medical, and other legally recognized exemptions regarding vaccination status will be considered.
Apply tot his job
Apply To this Job