Job Description
Associate Director, Quality Assurance page is loaded
Associate Director, Quality Assurance
Apply locations ACM - York Building 23 time type Full time posted on Posted 3 Days Ago job requisition id REQ_195463HOW WE CARE FOR YOU:
At ACM Global Laboratories we are dedicated to getting health care right. Our robust benefits and total rewards foster employee wellbeing, professional development and personal growth. We care for your career while improving patients’ lives.
- Auto Enrolment Pension
- Comprehensive Benefits Package
- Career Advancement Opportunities including Apprenticeships
- Comprehensive Career Pathways
SUMMARY:
The Director, Quality Assurance is responsible for implementing strategies that allow ACM Global Laboratories to successfully deliver high quality Clinical Trials studies; by driving effective, efficient, global processes across the various aspects of our Quality and Operations. This leader partners closely with the Clinical Trials Leadership team to drive outcomes that meet and exceed client expectations.
ACM Global Laboratories is a growing international organization that provides continued opportunities for internal advancement . At ACM you will be part of a team that is focused on improving people’s lives where you are supported by leadership and colleagues. We are backed by a large healthcare network in the complex and rewarding f ield of advanced laboratory science . Your voice is heard, and with that, you have an ability to make an impact on the organization and influence your professional growth
STATUS: Full Time
LOCATION : Hybrid – York, UK
DEPARTMENT: Quality
SCHEDULE: Days
ATTRIBUTES:
- Bachelor’s Degree required; Master’s Degree preferred
- 7 years of experience in Quality Assurance, Regulatory Affairs, Laboratory Operations or a related field required.
- 3 years in progressive leadership experience required.
- Experience managing quality/regulatory department of regional responsibility
- Experience with data privacy regulations preferred
- Experience with Medicines & Healthcare products Regulatory Agency (MHRA), Food & Drug Administration (FDA); knowledge of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP) strongly preferred.
RESPONSIBILITIES:
- Leadership Partner strategically with Global Quality Assurance team, and Global Leadership Team, while providing regional oversight of Quality Assurance teams. Oversee daily management activities for a regional Quality Assurance Team. Promote and uphold a high performing culture through effective talent planning, selection, onboarding and continuing education. Curate and deliver comprehensive training plans and materials to foster successful onboarding and employee performance. Provide ongoing coaching and mentorship supported by routine performance metrics to identify clear performance feedback and career development plans.
- Quality Assurance Identify and implement strategies to maintain a culture of quality. Develop and execute holistic audit program, including internal audits, vendor audits, client audits and regulatory inspections, to ensure compliance. Leverage industry knowledge to refine our strategies and processes for delivering high quality clinical trials. Maintains working knowledge of industry and regulatory standards and requirements. Provide guidance and leadership as it relates to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), MHRA, FDA, data privacy and other regulatory standards as needed or directed. Serve as a responsive escalation point for Clinical Trials quality issues and concerns.
- Process Improvement Develop and execute processes to drive effective, efficient, and compliant clinical trials and lab operations. Create, refine, review, and mitigate quality Key Process Indicators (KPI’s) for trends and drive improvements.
- Compliance Oversee and manage vendor management program to ensure supply compliance. Oversee and manage computer systems validation program to ensure compliance. Oversee and manage data privacy program regionally to ensure compliance. Represent ACM Global Laboratories at client meetings, regulatory audits, and more.
EDUCATION:
LICENSES / CERTIFICATIONS:
PHYSICAL REQUIREMENTS:
S - Sedentary Work - Exerting up to 10 pounds of force occasionally Sedentary work involves sitting most of the time, but may involve walking or standing for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.Rochester Regional Health is an Equal Opportunity/Affirmative Action Employer.
Minority/Female/Disability/Veterans by a prospective employee and/or employee’s Physician or delegate will be considered for accommodations.
About Us
At ACM Global Laboratories, we understand that every project we work on, every task we complete impacts patients and their families. Our dedication to being purposefully patient-driven is reflected in the high-quality work provided by our teams every day around the globe.
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