The Sr. Quality Compliance Specialist is responsible for assisting in the coordination and implementation of Good Clinical Practice (GCP) related quality assurance activities. These responsibilities include supporting the execution and maintenance of the risk-based audit program focused on internal and external GCP audits to ensure that clinical trials are conducted in compliance with applicable regulations, ICH GCP guidelines, and MedSource policies and procedures. The Sr. Quality Compliance Specialist manages the tracking of Quality Issues (QIs), Corrective and Preventive Actions (CAPAs) and Deviations and assists with sponsor audits as needed. The Sr. Quality Compliance Specialist is responsible for assisting in the development of departmental processes and procedures as well as reviewing and providing input on cross-functional processes and procedures.
DUTIES AND RESPONSIBILITIES:
- Collaborate with the Director, QA and Manager, QA to implement the quality management system (QMS) for MedSource.
- Coordinate and manage MedSource policies, procedures and associated controlled documents throughout the development, review, revision and archiving process.
- Ensure processes and procedures are updated to reflect regulatory trends, technological changes and best practices.
- Manage and facilitate the QI, CAPA and Deviations processes.
- Review, track and perform follow up activities for QIs, CAPAs and Deviations.
- Compile trend analyses of GCP quality system metrics such as QIs, CAPAs and Deviations and report to QA Management.
- Assist in the preparation and conduct of internal and external audits as needed and ensure compliance with associated processes.
- Support concurrent clinical efforts by consulting on projects and representing QA in interactions with customers.
- Interface with clients, internal and external stakeholders, and vendors, as needed.
- Support company regulatory GCP inspections, as needed
- Foster an environment that supports compliance and drive continuous improvement activities with emphasis on root cause analysis.
- Work with the Director, QA and Manager, QA to establish, maintain, and distribute metrics for monitoring quality system effectiveness.
- Advise/coach/train staff to ensure compliance with internal and external policies, laws, and regulations.
MINIMUM JOB REQUIREMENTS / QUALIFICATIONS:
- Minimum requirement of a Bachelor’s degree in a scientific discipline.
- At least 8 years of experience in the Pharmaceutical/Biotech industry, specifically within GCP.
- Minimum of 5 years of relevant QA experience and increasing responsibility in the Pharmaceutical/Biotech industry in a GCP quality role.
- GCP experience required and participation in regulatory inspections in highly desired.
- Ability to travel as needed (10-20%).
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
- Demonstrate in depth knowledge of the drug development process (early through late stages), trial design, data and trial management procedures.
- Ability to compile and interpret quality metrics.
- Strong working knowledge of regulatory requirements and GCP guidelines and ability to apply them in daily practices.
- Excellent verbal and written communication skills with the ability to work well in teams or independently and able to prioritize work and manage multiple projects while maintaining quality work.
- Strong analytical and writing skills to identify issues, solve problems and document them appropriately.
- Strong organizational and project management skills, attention to detail, and professionalism required.
- Ability to manage and coordinate multiple projects and assignments in a demanding fast-paced environment with changing priorities and activities.
- Ability to work with others as part of a collaborative team and negotiate effective solutions; strong interpersonal and social skills.
- Consistently exercises discretion and independent, sound judgment in the performance of the duties described above.
- Computer literacy in Microsoft Office Suite (MS Word, Excel and PowerPoint).
- Requires a highly motivated, resourceful, creative, decisive self-starter that can set goals, shift priorities, and work collaboratively to ensure regulatory compliance and high-quality results.
CONDITIONS OF EMPLOYMENT:
Verification of educational requirements, employment history, professional references, and certifications/training.
WORKING CONDITIONS AND PHYSICAL EFFORT:
- Work is normally performed in a typical interior/office work environment.
- No or very limited physical effort required.
MedSource is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
Please submit your resume to firstname.lastname@example.org.