What are the responsibilities and job description for the Vice President of Quality and Compliance (Mansfield, Massachusetts) position at eClinical Solutions?

eClinical Solutions helps life sciences organizations around the world accelerate clinical development initiatives with expert data services and the elluminate Clinical Data Cloud - the foundation of digital trials. Together, the elluminate platform and digital data services give clients self-service access to all their data from one centralized location plus advanced analytics that help them make smarter, faster business decisions.

OVERVIEW

The Vice President, Quality and Compliance is responsible for the development and management of the Quality Management System (QMS) and Compliance related Certifications. Further this role is instrumental in management of the Risk and Compliance Program and supporting a compliant culture within the company. Additionally, working with Legal and IT this individual helps ensure the organization Privacy Program is in line with current governing laws and regulations. and Record Retention Officer (RRO).

KEY TASKS & RESPONSIBILITIES

Ownership of the QMS including Customer, Vendor, and Internal Audit Programs, QMS Related Training, and Corrective and Preventative Action Management
Responsible for ensuring the maintenance, support and audit of all Policies, SOPs, and Work Instructions, and that the QMS is in line with applicable company programs and regulations, such
Ownership of the Risk and Compliance Process along with Tracking and Trending of issues
Ownership of Process Training Development and Delivery for all aspects of the QMS and Regulatory areas pertinent to the business
Partner with Business Development, Biometrics Services, and Customer Success teams on Customer questions, RFIs, and Bid Defense activities as needed

CANDIDATE'S PROFILE

Education / Language

Bachelor of Science degree in health-related field or equivalent and / or equivalent work experience along with advanced education in Business Administration or equivalent work experience preferred

20 years' experience in Pharmaceutical / Biotechnology industry or equivalent Senior consulting role with at least 10 years of direct Document Control and / or Quality Systems experience in a GCP setting preferred

10 years' experience with Risk and Compliance programs across a Regulated environment preferred

Excellent knowledge of English

Professional Skills & Experience

Strong knowledge of ICH / GCP guidelines, 21 CFR Part 11 and clinical trial methodology

Strong knowledge and the ability to develop and maintain an effective of Quality Management System

Experience planning, performing, and hosting customer, internal, and vendor audits

Team leadership skills including scope management, work planning and work delegation

Basic negotiation, influencing, and conflict management skills to interact effectively with peers, management, clients, and vendors

Previous management experience required, includes hiring and retaining staff and managing remote staff

Self-motivated with the ability to initiate and follow through on assignments

Ability to work professionally with highly confidential information

Excellent verbal, interpersonal and written communication skills

Detail oriented, ability to multitask with strong prioritization, planning and organization skills

Technical Skills & Experience

Proficiency in Microsoft Office Applications

Familiarity with EDC and Clinical Data Management Systems

Accelerate your skills and career within a fast-growing company while impacting the future of healthcare. We have shared our story, now we look forward to learning yours!

eClinical is a winner of the 2023 Top Workplaces USA national award! We have also received numerous Culture Excellence Awards celebrating our exceptional company vision, values, and employee experience. See all the details here : https : / / topworkplaces.com / company / eclinical-solutions /

eClinical Solutions is a people first organization. Our inclusive culture values the contribution that diversity brings to our business. We celebrate individual experiences that connect us and that inspire innovation in our community. Our team seeks out opportunities to learn, grow and continuously improve. Bring your authentic self, you are welcome here!

We are proud to be an equal opportunity employer that values diversity. Our management team is committed to the principle that employment decisions are based on qualifications, merit, culture fit and business need.

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Vice President of Quality and Compliance (Mansfield, Massachusetts)

What are the responsibilities and job description for the Vice President of Quality and Compliance (Mansfield, Massachusetts) position at eClinical Solutions?

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