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Sr Manager, Clinical Compliance
2 months ago
Job Summary
- Oversees a comprehensive compliance program for Hologic Diagnostic Solutions Clinical Affairs.
- Responsible for architecting, managing and overseeing the governance and strategic framework for clinical compliance to support the Diagnostic Solutions organization.
- Effectively fosters and further strengthens a culture of integrity, drives clinical compliance risk and opportunity management through state-of-the-art compliance programs. Champions continuous improvement of the compliance program, supporting the organization with an effective and proactive business-oriented approach.
- Manages the development and oversight of a robust Clinical Quality Management System to ensure that clinical research activities are carried out in accordance with applicable company policies and procedures, and applicable laws, regulations, and guidelines.
Essential Duties and Responsibilities
- Accountability to set the strategic direction and roadmap for clinical compliance, engaging a multitude of stakeholders and working cross-functionally
- Acts as key enabler of sustainable business operations by providing highest quality clinical compliance direction that includes the identification, management and improvement of key risks towards assurance
- Leads the development, approval, and periodic review of controlled documents related to clinical study processes and systems including policies in compliance with global regulatory standards
- Maintains expert knowledge of current and proposed clinical research related laws, regulations, guidelines and initiatives. Actively collects and disseminates clinical regulatory intelligence to the organization by participating in industry and regulatory working groups.
- Aligns with divisional and corporate leadership in Quality Assurance, Regulatory Affairs, Program Management, Finance, Scientific Affairs and others to ensure synergy and consistency across programs and product lines
- Participates with other senior leaders in Clinical Affairs to establish strategic plans and objectives for efficient Clinical execution in line with strategic objectives
- Ensures audits of clinical trial master files, clinical trial sites, clinical suppliers, and clinical department systems are conducted and reported on a periodic or as-needed basis; responsible for hosting corporate auditors and regulatory inspectors
- Assumes responsibility for the core training and career development of direct reports and actively ensures that they receive appropriate management and technical support and training
Qualifications
Education
- Minimum BA/BS degree in Life Sciences or equivalent qualification
- Professional certification (Association of Clinical Research Professionals (ACRP), Society of Clinical Research Associates (SoCRA), Regulatory Affairs Certification (RAC), Society for Quality Assurance (SQA)) a plus
Experience
- Experience (minimum 8 years) in Audit, Compliance, Risk, Assurance and Governance, ideally with international and team leadership experience in clinical research. Experience in an in vitro diagnostic device (IVD) environment is highly preferred.
- Strong knowledge of relevant international clinical compliance policies and regulations, and solid understanding of the diagnostics and healthcare industry.
- Intercultural understanding and experience in change and project management.
Skills
- Expert knowledge of global regulations and in particular US and EU regulations relevant to Medical Device and IVD clinical trials and Quality Systems, including Good Clinical Practices and Good Manufacturing Practices
- Proven business experience in the biotech and/or medical device industry, including comprehensive understanding of strategy, priorities, products and IVD market conditions in a global setting.
- Enterprise mindset that can break down silos. Ability to bring people together to work towards the same purpose across organization boundaries. Track record in directly and/or indirectly leading teams in multicultural and matrix environments.
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.
The annualized base salary range for this role is $137,600 to $208,300 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.
Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.
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