Clinical Operations Quality Manager
Hologic, Inc. · United States
- Hybrid
- Full-time
- $182,000 / year
- United States
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Job highlights
- Lead clinical trials with a focus on quality.
- Ensure GCP and regulatory compliance.
- Manage CROs and external vendors.
- Develop and maintain quality processes.
- Remote role in medical device innovation.
About the role
Clinical Operations Quality Manager
As a key member of the Breast and Skeletal Health (BSH) Clinical Affairs team, the Clinical Operations Quality Manager will oversee and execute major US-based and global clinical trials across multiple phases of product development, with a strong focus on quality oversight and quality assurance.
You will work alongside a high-performing team of clinical development and operations experts to generate high-quality clinical evidence in support of innovative breast and skeletal health technologies. This role requires close collaboration with global regional teams and cross-functional partners, including Clinical Development, R&D, Program Management, Regulatory Affairs, Legal, Marketing, Service, and Operations.
This position is ideal for a seasoned clinical operations professional with broad experience who can apply professional concepts and company objectives to resolve complex issues in creative and effective ways, while ensuring the highest standards of quality and compliance. This is a remote opportunity.
Key Responsibilities
- Lead the planning, execution, and oversight of clinical studies from start-up through close-out, ensuring trials are conducted according to established quality standards, protocols, and regulatory requirements.
- Ensure adherence to Good Clinical Practice (GCP), ICH guidelines, and all applicable regulatory standards for clinical trials.
- Critically review study-related documentation, including protocols, informed consent forms, site instructions, study manuals, eCRFs, data review plans, IRB submissions, IDE applications, and other trial documentation.
- In collaboration with the Clinical team, select and manage CROs and other external vendors/consultants, including:
- Contract and budget negotiation
- Oversight of CRO activities from award through trial closeout
- Oversee quality assurance and monitoring activities related to clinical trials.
- Contribute to the creation, review, and maintenance of Standard Operating Procedures (SOPs) governing clinical operations activities.
- Participate in the preparation of regulatory filings and support interactions with regulatory bodies, as needed.
- Develop and implement processes and tools to improve the efficiency and effectiveness of clinical operations from a quality perspective.
- Implement and maintain quality assurance processes, including audits, monitoring, and quality control checks.
- Identify, manage, and resolve deviations from established quality standards and procedures; initiate and support CAPA as required.
- Prepare reports on quality metrics and maintain accurate, timely documentation of quality-related activities in the Quality Management System (QMS).
- Perform other function-related duties as required by business needs.
Qualifications
Education & Experience
- Bachelor’s Degree required with 8+ years of relevant experience; or Master’s Degree with 6+ years of experience; or PhD with 3+ years of experience.
- Experience running clinical trials and working for a sponsor or CRO in the medical device industry.
- Experience developing and managing academic–industry partnerships.
- Proven experience in the management of quality processes within clinical operations.
Skills & Competencies
- Strong track record in managing complex clinical studies and trials, ideally in medical devices.
- Clinical or research experience in breast cancer screening, diagnostics, and/or treatment domains strongly preferred.
- In-depth understanding of quality processes and regulatory requirements in the medical device space, including GCP and ICH guidelines.
- Demonstrated ability to conduct audits and quality checks, and to initiate and manage CAPA when required.
- Excellent oral and written communication skills, including strong presentation skills and the ability to effectively represent and communicate the company’s position to internal and external stakeholders.
- Proven interpersonal skills and success in a matrixed, cross-functional environment.
- Strong organizational skills with the ability to multi-task, manage multiple projects, and adapt to changing priorities.
- Strategic thinker with the ability to set and manage priorities and allocate resources effectively.
- Collaborative, team-oriented mindset with a focus on achieving shared goals.
So why join Hologic?
We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.
The annualized base salary range for this role is $116,500 - $182,200 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.
Key skills/competency
- Clinical Operations
- Quality Assurance
- GCP
- ICH Guidelines
- Medical Device
- Clinical Trials
- SOPs
- Audits
- CAPA
- Regulatory Affairs
Skills & topics
- Clinical Operations Manager
- Quality Assurance
- GCP
- ICH Guidelines
- Medical Device
- Clinical Trials
- SOPs
- Audits
- CAPA
- Regulatory Affairs
- Clinical Research
- Sponsor
- CRO
- Project Management
- Healthcare
- Biotechnology
- Life Sciences
- Quality Management System
- Remote Work
- Manager
How to get hired
- Tailor your resume: Highlight your experience in medical device clinical trials and quality management, using keywords from the job description like 'GCP', 'ICH', and 'CAPA'.
- Showcase your quality expertise: Quantify your achievements in managing clinical trial quality, audits, and SOP development.
- Prepare for behavioral questions: Be ready to discuss how you handle complex issues, manage cross-functional teams, and ensure compliance in a remote setting.
- Research Hologic: Understand their mission in breast and skeletal health and demonstrate how your skills align with their innovative technologies.
Technical preparation
Master GCP and ICH guidelines thoroughly.,Practice reviewing clinical trial documentation.,Familiarize with QMS and CAPA processes.,Understand medical device regulatory landscape.
Behavioral questions
Describe managing quality in complex trials.,How do you ensure regulatory compliance?,Share an experience resolving quality deviations.,How do you collaborate cross-functionally?
Frequently asked questions
- What is the typical career progression for a Clinical Operations Quality Manager at Hologic?
- While specific paths vary, successful Clinical Operations Quality Managers at Hologic often advance into senior leadership roles within Clinical Affairs, such as Director of Clinical Operations or Head of Quality Assurance. Continued development and training are emphasized, offering opportunities for growth within specialized areas or broader operational management.
- What are Hologic's expectations regarding remote work for this Clinical Operations Quality Manager role?
- This Clinical Operations Quality Manager position is a remote opportunity, meaning you can work from home. Hologic is committed to enabling their remote workforce with the necessary tools and support for success, focusing on maintaining high standards of quality and collaboration regardless of physical location.
- How does Hologic support professional development for its Clinical Operations Quality Managers?
- Hologic is dedicated to talent growth, providing comprehensive initial training and ongoing development opportunities throughout your career. This includes continuous learning programs and resources designed to keep you updated on the latest advancements in clinical operations and quality assurance within the medical device industry.
- What specific therapeutic areas are most relevant for the Clinical Operations Quality Manager role at Hologic?
- While the role has a broad focus on clinical operations quality, experience or research in breast cancer screening, diagnostics, and/or treatment domains is strongly preferred. This specialization aligns with Hologic's commitment to innovative breast and skeletal health technologies.
- How does Hologic handle quality assurance and compliance in its clinical trials?
- Hologic emphasizes a strong focus on quality oversight and assurance in all clinical trials. This includes ensuring adherence to GCP, ICH guidelines, and regulatory standards, critical review of documentation, managing external vendors, conducting audits, and implementing CAPA processes to maintain the highest quality and compliance standards.
- What is the salary range for a Clinical Operations Quality Manager at Hologic?
- The annualized base salary range for this role is $116,500 - $182,200, and the position is bonus eligible. The final compensation will be determined by factors such as your experience, skills, education, and the specific business needs and market demand.