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, and 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, including contract and budget negotiation. Oversight of CRO activities from award through trial close-out.

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 Corrective and Preventive Actions (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:

• Bachelors Degree required with 8 years of relevant experience or
• Masters 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 companys 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. 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.

Agency and Third-Party Recruiter Notice:

Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition, Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.

As part of our commitment to a fair and accurate evaluation of each candidates qualifications, we require all applicants to refrain from using AI tools such as generative AI or automated writing assistance during any stage of the interview process. Responses influenced by AI may result in disqualification. We appreciate your understanding and cooperation in ensuring a transparent and equitable selection process.

Hologic Inc. is proud to be an Equal Opportunity Employer, inclusive of disability and veterans.