VP of Quality and Compliance

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 serves as the Data Protection Officer (DPO) 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 as Business Continuity Planning, Data Retention, and Data Integrity 

• 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 

• Serves as the Company Data Protection Officer (DPO) as required under the EU General Data Protection Regulation (GDPR) 

• In partnership with Legal and IT, Provide Company Direction and management of Security and Privacy initiatives to ensure the maturity of the companies Data Privacy Program  

• Provide oversight and direction for Validation of Computer Systems including the compliance for existing, modified and new Business Systems  

• Serve as Company lead on SOC2, ISO 27001/ 27001, HIPAA, and Data Privacy Framework Certifications  

• 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 (Master of Business Administration degree preferred)  

• Excellent knowledge of English 

Professional Skills & Experience 

• Minimum 20 years 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.  

• Minimum of 10 years’ experience with Risk and Compliance programs across a Regulated environment  

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

• Strong Knowledge of software validation principles  

• Experience with implementation, validation and maintenance of an electronic documentation and/or data management system 

• 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  

• Working knowledge of Data Privacy Regulations including GDPR 

• Strong technical project management experience and 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 

• Strong familiarity with IT infrastructure in a regulated environment 

• Experience in IT Control Frameworks, such as NIST 

• Working knowledge and experience with SOC2 Type 2 and ISO 27001/27701 controls and certification processes 

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.