Manager, Clinical Quality and Compliance
2 months ago
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Youâll also have access to:
Career development with an international company where you can grow the career you dream of .
Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
An excellent retirement savings plan with high employer contribution
Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelorâs degree.
A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.
The Opportunity
This position works out of our Portland, Maine location.  The position of Manager, Clinical Quality and Compliance s within our Infectious Disease business unit. In this role, the Manager of Clinical Quality and Compliance will provide guidance and support for ARDx ID Clinical Operations including oversight of clinical quality activities and ensure clinical trials are conducted in a manner compliant with SOPs, ICH/GCP/regulatory guidelines and company goals.Â
Â
What Youâll Work On
Identify, communicate and provide solutions to clinical trial issues and/or risks.
Ensure clinical quality and compliance team members are aligned with project objectives.
Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and procedures.
Ensure the execution of training plans, SOP review, and understanding and adherence to SOP training matrix.
Ensure quality deliverables, including identifying quality risks, and developing corrective action plans to prevent and/or correct deficiencies.
Maintain current knowledge of therapeutic areas, SOPâs, IVDR and ICH-GCP guidelines.
Oversee management of clinical quality documentation, ensuring all policies and procedures are current and compliant.
Identify and develop risk management and contingency plans.
Participate in vendor selection process for outsourced activities as applicable.
Responsible for clinical quality incident reporting, corrective and preventative actions, and supplier corrective action requests.
Share and promote the best practices within the team to enhance performance.
Carry out duties in compliance with established business policies.
Assist in developing regulatory approach to market clearance. Prepare and/or provide review of submission documentation for clinical trials and/or product clearance as needed.
Support regulatory audits and inspections.
Interact with other managers across multiple functional areas to facilitate smooth work processes and communication. This may include involvement in the design change process and quality system regulation.
Provide ongoing training for staff and develop (in conjunction with the Director, Global Clinical Operations) performance metrics, as well as communicate and implement performance goals aligned with corporate strategic imperatives.
Mentor/coach direct up to 5 reports.
Contribute to the selection process of new hires, including reviewing candidate credentials, interviewing candidates, and making hiring recommendations. Recruit, hire, train, and manage assigned MCSO personnel and their career development.
Required Qualifications:
BS/BA degree in science or related field.
8+ yearsâ experience in Good Clinical Practice (GCP) and/or Quality Assurance Environment, including 5+ years clinical study/project management experience
Broad knowledge of IVDR, ICH, GCP, IRB/IEC, and local regulatory authority for diagnostic & assay development regulations.
PREFERRED QUALIFICATIONS | EDUCATION/EXPERIENCE:
Masterâs degree preferred.
At least 2 years of management experience in a similar role.
Prior experience managing clinical trials for or within the biotech or device industry, including CRO management, clinical site monitoring, and knowledge of the basic data management processes.
Ability to work within established timelines, in a fast-paced environment.
Prior IVDR/IVD experience/Clear understanding of relationship of diagnostic test results to patient clinical diagnosis/treatment
Proven leader with passion and skills for strategic and critical thinking, problem solving, motivating and mentoring team members
Ability to understand strategic goals and match to the business needs of the company.
Ability to independently manage and provide significant tactical leadership and guidance.
Excellent matrix leadership.
Embody a culture of improvement and progress; promote knowledge sharing.
Strategic thinking and analytical skills. Strong written and verbal communication skills.
Superior organization skills with excellent attention to detail.
Excellent computer skills and knowledge of Microsoft Office and the ability to learn appropriate software.
* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:Â www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.
The base pay for this position is $83,000.00 â $166,000.00. In specific locations, the pay range may vary from the range posted.
-
Clinical Quality and Compliance Manager
6 days ago
South Portland, Maine, United States Abbott Laboratories company Full timeAbout Abbott LaboratoriesAbbott Laboratories is a leading global healthcare organization dedicated to enhancing the quality of life for individuals at every stage of their health journey. Our extensive range of innovative technologies encompasses various healthcare sectors, including diagnostics, medical devices, nutritional products, and branded generic...
-
Clinical Quality and Compliance Manager
5 days ago
Portland, Maine, United States Abbott Laboratories company Full timeAbout Abbott LaboratoriesAt Abbott Laboratories, we offer an environment where you can engage in meaningful work, pursue personal growth, and enjoy a balanced life.Benefits You Will Enjoy:Career advancement opportunities within a global organization.Comprehensive medical coverage for employees through our Health Investment Plan (HIP) PPO.A robust retirement...
-
Head of Clinical Quality Management
7 hours ago
South San Francisco, California, United States GQR Full timePosition Title: Director of Clinical Quality AssuranceLocation: South San FranciscoEmployment Status: Full-time direct hire; Hybrid role with 3 days onsiteThe Director of Clinical Quality Assurance (CQA) plays a pivotal role in overseeing that clinical trials comply with relevant GCP regulations, including FDA guidelines, international standards, and...
-
Ambulatory Clinic Practice Manager
1 month ago
Portland, United States Clinical Management Consultants Full timeA fantastic career opportunity for an Ambulatory Clinic Practice Manager is now available with a community-based and historic Hospital in Eastern Oregon! The Ambulatory Clinic Practice Manager will be part of a dedicated group of professionals with the resources, training, and expertise to provide patients with the most advanced medical care. The Medical...
-
Head of Clinical Quality Management
4 hours ago
South San Francisco, California, United States GQR Full timePosition Title: Director of Clinical Quality AssuranceLocation: South San FranciscoEmployment Status: Full-time direct hire; Hybrid role with 3 days onsiteThe Director of Clinical Quality Assurance (CQA) is a pivotal role that entails a hands-on approach to ensuring that clinical trials comply with relevant GCP regulations (including FDA, international...
-
Head of Clinical Quality Management
3 hours ago
South San Francisco, California, United States GQR Full timePosition: Director of Clinical Quality AssuranceLocation: South San FranciscoEmployment Type: Full-time direct hire; Hybrid role 3 days a week onsiteThe Director of Clinical Quality Assurance (CQA) is a pivotal role that demands a proactive approach to ensure that clinical trials comply with relevant GCP regulations (including FDA, international, and...
-
Compliance and Quality Officer
2 months ago
Portland, Oregon, United States OnPoint Community Credit Union Full timeJOB SUMMARYUnder direction of the Enterprise Risk Officer- Retail Delivery, this position performs a variety of risk-based engagements to support the achievement of Retail Delivery objectives. The Compliance and Quality Control Officer- Retail Delivery is primarily responsible for the development, implementation and oversight of quality control and...
-
International Trade Compliance Analyst
6 days ago
Portland, Oregon, United States Trade Compliance Recruiting Solutions Full timeOVERVIEWManage and support the Trade Compliance operations, primarily focusing on export activities. This is a self-directed position. While onsite work is preferred, remote arrangements may be considered initially, with extensive travel required to gain a comprehensive understanding of the role, followed by occasional travel or potential relocation...
-
Clinical Quality Manager
3 months ago
Portland, United States SCA Health Full timeOverview:Today, SCA Health has grown to 11,000 teammates who care for 1 million patients each year and support physician specialists holistically in many aspects of patient care. Together, our teammates create value in specialty care by aligning physicians, health plans and health systems around a common goal: delivering on the quadruple aim of high-quality...
-
Quality Compliance and Testing Specialist
3 months ago
Portland, United States Lazarus Naturals Full timeJob DescriptionJob DescriptionOverview: Lazarus Naturals is on a mission to make quality hemp-based CBD accessible to everyone. It’s why we own our manufacturing process from start to finish—from our hemp farms in Central Oregon, to our extraction, formulation, and packaging—it’s all designed to deliver safe, effective CBD at an affordable price for...
-
Clinical Quality Management Analyst
2 days ago
South San Francisco, United States TALENT Software Services Full timeAre you an experienced Clinical Quality Management Analyst with a desire to excel? If so, then Talent Software Services may have a job for you! Our client is seeking an experienced Clinical Quality Management Analyst to work at their company 100% remotely.Position Summary: This job will deliver value to the Health Plan, and its beneficiaries enrolled in Risk...
-
Quality Compliance Inspector
6 days ago
South Windsor, Connecticut, United States Jobot Full timeJob Overview:We are currently seeking a meticulous and dedicated Quality Inspector to join our team in the aerospace sector. This role is essential in maintaining the integrity and reliability of our production processes and outputs through comprehensive inspections and evaluations.About Us:We are a leading company in the aerospace and defense industry,...
-
Head of Clinical Quality Assurance
5 days ago
South San Francisco, California, United States GQR Full timePosition: Clinical Quality Assurance DirectorLocation: South San FranciscoEmployment Type: Full-time direct hire; Hybrid role with 3 days onsiteThe Clinical Quality Assurance Director is a pivotal role focused on ensuring that clinical trials comply with relevant GCP regulations (such as FDA, international, and country-specific guidelines), ICH standards,...
-
Head of Clinical Quality Assurance
6 days ago
South San Francisco, California, United States Pliant Therapeutics Full timePliant Therapeutics is a leading biopharmaceutical organization dedicated to the innovation and advancement of groundbreaking treatments for fibrotic diseases. Established by Third Rock Ventures alongside esteemed academic experts, Pliant is committed to addressing the critical medical needs of healthcare providers, patients, and families affected by...
-
Director, Clinical Quality Assurance
4 weeks ago
South San Francisco, United States GQR Full timeTitle: Director, Clinical Quality AssuranceLocation: South San FranciscoStatus: Full-time direct hire; Hybrid role 3 days a week onsiteThe Director of Clinical Quality Assurance (CQA) is a hands-on position responsible for ensuring clinical trials adhere to applicable GCP regulations (e.g., FDA, ex-US, country-specific), ICH guidelines, Standard Operating...
-
Director, Clinical Quality Assurance
4 weeks ago
South San Francisco, United States GQR Full timeTitle: Director, Clinical Quality AssuranceLocation: South San FranciscoStatus: Full-time direct hire; Hybrid role 3 days a week onsiteThe Director of Clinical Quality Assurance (CQA) is a hands-on position responsible for ensuring clinical trials adhere to applicable GCP regulations (e.g., FDA, ex-US, country-specific), ICH guidelines, Standard Operating...
-
Clinical Quality Assurance Director
3 hours ago
South San Francisco, California, United States GQR Full timePosition Title: Director of Clinical Quality AssuranceLocation: South San FranciscoEmployment Status: Full-time direct hire; Hybrid role with 3 days onsiteThe Director of Clinical Quality Assurance (CQA) is a pivotal role that demands active engagement in ensuring that clinical trials comply with relevant GCP regulations (such as FDA, international, and...
-
Manager, Clinical Operations
2 months ago
South Portland, United States Abbott Laboratories Full timeWorking at AbbottAt Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. Youâll also have access to:Career development with an international company where you can grow the career you dream of .Free medical coverage for employees* via the Health Investment Plan (HIP) PPOAn excellent...
-
Head of Clinical Quality Assurance
3 hours ago
South San Francisco, California, United States GQR Full timePosition: Clinical Quality Assurance DirectorLocation: South San FranciscoEmployment Type: Full-time direct hire; Hybrid role with 3 days onsiteThe Clinical Quality Assurance Director is a pivotal role that demands a proactive approach to guarantee that clinical trials comply with relevant GCP regulations (such as FDA, international, and country-specific),...
-
Regulatory Compliance Manager
1 month ago
Portland, Oregon, United States ByHeart Full timeRole Description Reports to: Director of Quality Location: Portland, OregonStart Date: ASAP The Regulatory Compliance Manager will be responsible for the establishment, maintenance, planning, directing and coordinating of programs, procedures and processes necessary for manufacturing food ingredients in accordance with local, state and national...