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US - Quality Assurance GCP (Good Clinical Practice) - Specialist
3 months ago
Preferably Onsite Smyrna 2x week
Ensure candidates are okay with using their own laptop and downloading VDI
Clinical Development Quality Lead
Notes from HM:
Looking for an experienced Clinical Quality Assurance professional to support inspection readiness activities for key clinical program.
This role will involve working cross-functionally with internal departments and external organizations, such as CROs, to resolve quality issues to ensure inspection preparedness.
Specific responsibilities will include:
Co-lead inspection preparation meetings with team with a focus on inspection preparation at the study level for a key program.
Conduct Quality Control checks of the eTMF.
Support data integrity assessments.
Support the inspection readiness of investigator sites.
Conduct inspection risk assessments for CROs and vendors.
Provide guidance on compliance and regulations and ensure study teams are following targeted SOPs during study.
Help SMEs in the development of storyboards and functional area presentations.
The ideal candidate will possess:
Knowledge and interpretation of GCP regulations and standards, with understanding of phase appropriate application of GCP expectations.
Direct experience with FDA and/or EMA or other health authority inspections of sponsor, investigator site(s), and/or CRO(s).
Self-motivated with the ability to take initiative, ownership and manage responsibilities while shifting priorities quickly under tight timelines.
Strong analytical skills, problem solving techniques, and understanding of ensuring level of effort to address observations/quality issues is commensurate with risk.
- JOB SUMMARY
clinical development portfolio across the sites and departments and provide Clinical
Development Quality input to cross functional teams dealing with complex and/or important
projects and issues
Providing mentoring and guidance to other members of the Clinical Development Quality
team, supporting the Global Head and/or Regional Heads by deputizing for them at
meetings on request, and contributing to planning and resource prioritization decisions for
Clinical Development Quality activities
Partnering with Development Solutions in driving quality into the clinical activities across
the sites
Providing quality and compliance oversight as well as investigative support to
activities regulated by Good Clinical Practices (GCP)
JOB DESCRIPTION
sop-af-(phone number removed) V3.0
Refer to sop-(phone number removed)
Page 2 of 4
The above description is intended to describe the general content and requirements for the performance of this job. It is
not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Management has the right to
assign or reassign duties and responsibilities to this job at any time.
- MAJOR ACCOUNTABILITIES
To lead the development of a risk mitigation program for clinical programs,
prospectively identifying critical quality risk factors and their potential impact, and
developing efficient processes or solutions to manage the risks
To lead the overall Inspection Readiness process for preapproval GCP inspections or other
inspections involving the clinical programs
To support inspections and investigations conducted by international and national
authorities, including responsibility for the preparation and hosting of sponsor sites for
inspections
To independently plan, coordinate and execute Clinical Development Quality activities in
accordance with the risk mitigation plans to validate the systems and processes
established to ensure subject safety and protection and to ensure that clinical trials
performed, and data are generated in compliance with international and national GCPs
As required, review and coordinate the output of trends from audits and risk analyses
prepared by colleagues, providing senior management and peers in other departments with
a summary and analyses of the comparative risks and outcomes across multiple clinical
programs
To ensure resolution of audit findings through close collaborations with the audit &
compliance team. Utilize in-depth knowledge and understanding of current business trends,
applicable regulations and quality principles, to collaborate effectively and influence
approaches to quality, and ensure work products and output are aligned with regulatory
guidelines, ICH-GCP, other applicable regulatory requirements and global quality
standards
To represent Clinical Development Quality at interdepartmental and project team meetings
taking the leadership role when required, and dealing with complex and difficult or
important project issues
To deliver presentations to peers, senior management, and industry audiences, acting as a
role model for change
Helps develop, coach and mentor junior colleagues, generating enthusiasm and
encouraging new ideas.
JOB DESCRIPTION
- EDUCATION
Describe the minimum level of
education necessary for this role:
Bachelors
Experience
List the type and length of experience
10 plus years of background, knowledge and experience
of the (bio)Pharma industry and applicable technical
aspects of the business.
3 to 5 years previous experience on Clinical Quality
within a CRO or in Pharma
- COMPETENCIES
In-depth knowledge and understanding of ICH-GCP, applicable regulations (domestic and
international), quality principles, inspection preparation and hosting, risk management and relevant
business processes and techniques.
EEO:
"Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans."
