Compliance Manager, Clinical Quality Assurance Oversight

Thermo Fisher Scientific•Morrisville, NC

1d•Remote

About The Position

PPD, the Clinical Research business of Thermo Fisher Scientific is hiring for a Compliance Manager in our global Clinical Quality Assurance group. This is a home-based role for qualified candidates in the US- east coast or central time zone (band 7).

Requirements

Bachelor's degree or equivalent and relevant formal academic / vocational qualification
Previous compliance and quality experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years’ experience)
Working knowledge of Good Clinical Practices (GCP)
CRO/Pharma industry experience required
In some cases, an equivalency, consisting of appropriate education, training, and/or directly related experience will be considered sufficient for an individual to meet the requirements of the role.
Proven experience in building strong team and stakeholder relationships.
In‐depth knowledge of all Clinical Trial related FDA and EU regulations and ICH Guidelines.
Strong knowledge of Clinical Development processes according to Good Clinical Practices (GCP) and regulatory requirements.
Ability to motivate and educate clinical study teams on clinical quality aspects.
Ability to translate quality culture and ways of working to study teams.
Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
Able to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology with proficiency.
Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
Must be legally authorized to work in the United States without sponsorship.
Must be able to pass a comprehensive background check, which includes a drug screening.

Responsibilities

Provide Clinical Quality oversight and support for clinical study teams.
Dedicated, single point of Quality contact for client
Partners with Operations to establish a consistent Quality culture across clinical trial studies or portfolio
Provide directions and recommendations for issue avoidance
Continuous awareness and periodic review of QE/SSM/SB/sPIP/Audit/ Inspections
Escalate appropriately to Client Quality/Quality Partner/Strategic Alliance Lead/bPL/PDL/OD to minimize client impact and improve outcomes
Enable and Facilitate Quality Risk Management.
Prepare and analyze QA-related (e.g., QE, Audit, inspection) Key Quality Indicators for emerging trends and potential risks to mitigate/prevent issues
Promote compliance (i.e., timeliness, consistency, and accuracy) of client-specific requirements related to quality events / audit/ inspection responses
Incorporate quality insights into operational lessons learned and promote awareness across the portfolio.
Drive support Partnership Governance.
Co-chair Joint Quality Councils and be available to contribute to other governance meetings
Present quality metrics/trends and discuss potential resolution as required with relevant stakeholders