Data Integrity Quality Assurance Coordinator

Fast Switch

Data Integrity Quality Assurance Coordinator

Data Integrity Quality Assurance Coordinator #413518
Job Description:
 
Primary Responsibilities:
• Responsible for executing the Data Integrity Quality Assurance (DIQA compliance and oversight program, compliance gap assessments, and participating in related data integrity process improvement initiatives within M&D.
• Ensures consistent application of Data Integrity regulations and guidelines to GxP data generated and managed for clinical development by M&D or Service Providers to ensure compliance with global standards, policies, and procedures and regulatory requirements.
• Oversight of study specific software system builds used for clinical study operations, such as Interactive Response Technology (IRT), electronic Patient Reported Outcomes (ePRO), and electronic Case Report Forms (eCRF).
• Performs periodic review of IRT/eCOA User Acceptance Testing (UAT) documents for compliance to procedures.
• Develops, facilitates, and implements process improvements and supports new technology initiatives.
• Contributes to the development, implementation, and successful execution of the CRQA mission, objectives and 3-5 year strategic plan.
 
Essential Job Responsibilities:
1. Responsible for executing the DIQA compliance oversight program to oversee compliance to Data Integrity regulations and guidelines.
2. Executes the computerized systems validation program pertaining to clinical study operations, including reviewing and approving computerized system validation documentation for compliance with company policies and procedures. Reports status of validation projects to management.
3. Oversees and supports computer system validations and User Acceptance Testing of study specific software system builds for systems used for clinical study operations of Interactive Response Technology (IRT), electronic Patient Reported Outcomes (ePRO), and electronic Case Report Forms (eCRF). Including facilitating resolution of any potential compliance risks that arise during a study.
4. Executes scheduled periodic reviews of IRT/eCOA UAT documentation for study specific GxP regulated systems. To order to ensure systems are maintained under control and remain in a validated state. Identifies required revalidation/remediation activities and ensures activities are completed.
5. Responsible for executing the DIQA internal and vendor audit program to assess internal processes and computer software vendors and computer related service providers utilized by M&D. Responsible for scheduling and performing DI compliance assessments, audits, reporting audit findings, and working to ensure appropriate audit response and corrective actions are provided by the business.
6. Work closely with M&D business functions, Data Sciences, Clinical Sciences, QPOS, and ISS to ensure process control and improvements to ensure Data Integrity compliance and process improvement.
7. Facilitates and manages process improvement initiatives related data integrity control processes, and regulatory compliance assurance processes throughout M&D. Manages multiple assigned projects concurrently. Collaborates with key stakeholders and functional area customers across the organization (local and global) for process improvement initiatives and to communicate compliance issues to management.
8. Provides QA oversight of assigned projects to assure quality of output as well as compliance with standards, policies, procedures and regulations, including the global Electronic Records / Electronic signatures regulations (e.g. 21 CFR Part 11) and Data Integrity regulations and guidances.
9. Develops and utilizes tools to track and trend compliance metrics, and quality related issues; to ensure that M&D systems and procedures comply with internal company (global, regional, and site) and external regulatory agency standards for compliance and validation. Reports project and program status to QA management.
10. Participates in the development of a comprehensive risk management process and risk based approaches related to activities for data integrity process controls within M&D.
11. Authors, revises, and performs maintenance and administration of departmental controlled documents (i.e., policies, SOPs, WPDs, Forms, etc) as necessary. Conducts and coordinates compliance, and quality training as needed.
 
Quantitative Dimensions:
1. Reviews and assesses 50 to 100 IRT/eCOA UAT related documents per year.
2. Leads or participates in and reports 5-10 internal and/or data integrity assessments and vendor audits per year.
3. Supports the generation of periodic and ad hoc metrics reports of quality and compliance trends of document reviews and conducts an analysis of these metrics on a periodic basis for QA management and the business.
 
Required Qualifications:
1. Minimum of a Bachelor of Arts/ Bachelor of Science degree
2. Minimum 4 years experience in the pharmaceutical industry
3. Minimum of 4 years experience in quality assurance in the pharmaceutical industry
4. Minimum 4 years experience performing or overseeing Data Integrity compliance, software/system development life cycle and computer system validation.
5. Minimum 2 to 4 years supporting study specific computer system implementations.
6. Minimum of 4 years project management experience, preferably in a multicultural, global setting, requiring facilitation, negotiation, problem-solving, and conflict resolution skills.
7. Proficiency in Microsoft Office and SharePoint collaboration sites (or similar).
8. Ability to work 40 hours per week plus some overtime if required (approximately 5-10 hours overtime per week).
 
Skills and Competencies
1. In-depth knowledge of GxP regulations and computerized systems in GxP regulated environments, preferably for pharmaceuticals, relating to clinical product development, combined with broad knowledge of quality principals and industry trends.
2. In-depth knowledge of global industry standards and regulatory requirements for software development, computer system validation, data integrity and Electronic Records and Electronic Signatures regulations. Experience in these disciplines in the pharmaceutical industry.
3. GxP Regulated (FDA, EMA, MHLW, ISO, or other) computerized systems auditing experience in a pharmaceutical manufacturing or clinical development environment required. Ability to represent the company to external stakeholders during vendor audits and interacting with regulatory agencies.
4. Experience in developing and maintaining effective relationships with internal and external stakeholders for process improvement and issue resolution project teams. Collaborative skills to facilitate, manage, and work within project teams across departments and global organizations.
5. Strong interpersonal skills and multi-cultural /intercultural awareness; able to negotiate and build consensus for plans and priorities and able to develop effective relationships through collaboration. Forges strong working relationships with all colleagues and stakeholders.
6. Excellent oral and written communication as well as presentation skills.
7. Demonstrated ability to proactively predict and resolve complex problems, think strategically and tactically, generate solutions to complex problems and build consensus across the global organization. Able to generate insights and leverage learnings at the individual, team and functional level.
8. Strong planning and organizational skills and experience managing multiple priorities simultaneously.
 
Additional Info:
 
At Fast Switch – Great Lakes (FSGL), Our Purpose is Our People and Our Planet. We come to work each day and are reminded we are helping people find their success stories.  Isn’t that cool? Also, Doing the right thing is our mantra.  We act responsibly, give back to the communities we serve, and have a little fun along the way.
We at FSGL, have been doing this for 22 years with pride, dedication and plain old-fashioned hard work.
We're a financially strong, privately-held company that is 100% consultant and client focused.
We've differentiated ourselves by being fast, flexible, creative and honest. Throw out everything you've heard, seen, or felt about every other IT Consulting company. We do unique things, and we do them for Fortune 10 companies, Inc. 500 companies, and technology start-ups.
Our benefits are second to none and thanks to our flexible benefit options you can choose just the benefits that you need or want, options include:
 
• Medical and Dental (Fast Switch pays majority of the medical program)
• Vision
• Personal Time Off (PTO) Program
• Long Term Disability (100% paid)
• Life Insurance (100% paid)
• 401(k) with immediate vesting and 3% (of salary) dollar-for-dollar match
 
Plus, we have a lucrative employee referral program and an employee recognition culture.
One of our pride points as that in 2013, 2014, 2015, 2016, 2017, 2018 and 2019, Fast Switch was named one of the Top Work Places in Michigan by the Detroit Free Press.
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