74 applicants
WCG · 4 days ago
Manager Quality Assurance, Technology
Princeton, NJ
Full-time
Remote
Senior Level
$78K/yr - $122K/yr
5+ years exp
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Maximize your interview chancesClinical TrialsHealth Care
Hiring Manager
Sandra Ancira
Insider Connection @WCG
Responsibilities
Engage in the continued development, maintenance, and enforcement of the Quality Management System.
Manage/lead efforts with regard to the development and maintenance of quality goals, objectives, and process improvements.
Establish and enforce quality department standards.
Coach and train WCG staff on quality department standards and best practices.
Engage with WCG staff to author and revise internal technology standards (i.e. IT and/or Software Development Policies, SOPs, et al).
Ensure such standards are in conformity with applicable regulatory agency regulations and guidance.
Ensure such standards presented to employees for training.
Oversee and manage the implementation, development, and change management of systems to ensure same is performed in line with regulatory agency regulations and guidance, including but not limited to, GxP, 21 CFR Part 11/Annex 11, GDPR, and HIPAA.
Manage the integration, implementation, and/or development, of new WCG businesses and/or systems.
Serve as the primary technology quality liaison for the integration of new WCG business acquisitions and systems.
Serve as the subject matter expert with respect to the harmonization of processes and procedures.
Manage/lead the investigation of Quality Events/Corrective Actions Preventative Actions (CAPA), deviations, and notes to file (NTF).
Ensure proper investigation of such events is performed, and documentation maintained.
Manage/lead the conduct of internal audits to ensure internal standards and staff performance are in compliance with applicable WCG process, regulatory agency regulation and guidance.
Manage/lead the conduct of internal audits/periodic review of company policies and procedures.
Manage/lead the conduct of internal audits/periodic review of WCG systems.
Identify compliance gaps and provide support and suggestions for remediation. Report status of the quality levels of staff, systems and production activities to the VP, IT Compliance.
Maintain the compliance schedule of external vendor qualification to ensure that vendors remain in compliance with applicable WCG process.
Host external audits and inspections including communication with sponsor/agency, internal audit preparation activities, review of audit report, collection of responses, and follow-up on findings resolution.
Maintain current knowledge with respect to quality legislation and regulatory compliance best practice.
Provide training and guidance to staff regarding compliance and interpretation of regulations.
Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
Attendance and punctuality are essential functions of the position.
Qualification
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Required
Bachelor’s degree or local equivalent in medicine, science, technology or equivalent degree and years of experience.
Minimum of five (5) years’ experience in a quality/regulatory compliance position, with a proven track record of success in leading/managing quality assurance projects/assignments, audits, and resources as well as monitoring and tracking compliance standards.
Three (3) years’ experience in a management/leadership position responsible for hiring, developing and training a team of direct reports including establishing team goals and objectives.
Thorough knowledge of current regulatory (FDA & ICH) & GCP guidelines as they apply to clinical studies.
Demonstrated knowledge of 21 CFR Part 11 requirements and Computerized System Validation processes including SDLC.
Experience in leading Computerized System Validation efforts of systems used in Clinical Trials.
In-depth knowledge and understanding of drug development and the clinical trial process.
Strong organizational and planning skills.
Strong management skills with a proven record to influence and negotiation.
Effective communication (written and oral) skills, organization and interpersonal skills as well as the ability to interact with WCG staff, sponsors, and regulatory agencies as needed.
Highly developed problem-solving skills and the ability to resolve difficult conflicts.
Ability to multitask and to work efficiently and independently.
Preferred
Certifications for quality professionals through the Society for Quality Assurance and the American Society for Quality or comparable certifications are desirable.
Benefits
Health
Dental
Vision
Life Disability
401k with match
Flexible spending accounts
Employee Assistance Programs
Referral Bonuses
Tuition Reimbursement
Paid time off including holidays, vacation, and sick time
Opportunities for career development with on-the-job training, certification assistance, and continuing education reimbursement
Company
WCG
WCG provides clinical and technological services.
1,001-5,000 employees
H1B Sponsorship
WCG has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2021 (2)
2020 (5)
Funding
Current Stage
Late StageTotal Funding
unknownKey Investors
Leonard Green & Partners
2019-11-14Private Equity· Undisclosed
Leadership Team
Patricia Leuchten
Founder and CEO, WCG Avoca; Chief Change Officer, WCG
T
Todd A. Joron, BSc, MBA
Founder, President & Chief Operating Officer
Recent News
2024-05-24
Company data provided by crunchbase
