IT Quality Systems Analyst

TITLE:

IT Quality Systems Analyst

Title: IT Quality Systems Analyst

Reports To: Sr. R&D Systems Analyst

Location: Raleigh

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD). Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. Indivior is dedicated to transforming SUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category.

Indivior was founded to help tackle the opioid crisis, one of the largest and most urgent public health emergencies of our time.  Our purpose is to bring science-based, life-transforming treatments to patients.  We strive to help eliminate the stigma of addiction.  We take our role as a responsible steward extremely seriously and commit ourselves to cultivating our unique culture and highest standards of integrity.

We are driving forward our understanding of addiction and other serious mental health illnesses to create new science that will help pave the way for an even deeper understanding of patient needs and treatment innovation.  We engage at all levels across the addiction treatment spectrum, interacting with governments, key opinion leaders, physicians, payers, patients, and patient advocacy groups to raise awareness and educate about addiction as a chronic, relapsing disease.

Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/indivior.

POSITION SUMMARY:

The IT Quality Systems Analyst is responsible for performing IT end-user support and managing delivery of laboratory and quality systems at the Indivior Manufacturing Facility in Raleigh, NC.

This role will be a key contributor to impact the delivery of new system implementations to support the local and global sites. Role is responsible for performing operational/maintenance activities for systems and technology at Raleigh site and other global sites. When necessary, this role should partner with application vendors for their specific systems/technology to ensure functionality, maintenance, and operations to meet business needs. Role will contribute business process, technical configuration, and implementation experience to ensure quality delivery of IT systems and lab technology. The role will ensure consideration and compliance with all company standards.

ESSENTIAL FUNCTIONS:

The responsibilities of this role include, but are not limited to, the following:

• Performing system/technology maintenance (e.g., upgrades).
• Monitoring systems/technology (e.g., backups).
• End-user support.
• Audit Support.
• Authoring required Installation Qualification, Operational Qualification and Performance Qualifications for Qsystem deployment.
• Creating required deliverables as part of Indivior’s internal SDLC for upgrades, new installations, etc.
• Ability to develop and maintain effective relationships with internal and external stakeholders.
• Project and vendor management.
• Partner with IT Security to ensure systems are compliant with IT security standards.
• Supporting IT integrations and business process improvements.

MINIMUM QUALIFICATIONS:

Education: 4-year Bachelor’s Degree

Field of Study: Scientific or technical discipline with focus on Information Technology or Bioscience

Industry: Pharmaceuticals / Life science

Computer/Application Skills:  Windows, MS Office, ValGenesis, laboratory systems (e.g., OpenLab, LIMS), ServiceNow, Veeva Vault Quality, camera systems, environmental monitoring systems.

COMPETENCIES/CONDUCT:

In addition to the minimum qualifications, the employee will demonstrate:

Experience

• Pharmaceutical Lab IT experience and business process understanding at a GMP facility, preferably from working with / in multinational Pharma environments.
• Understanding of life science industry applications.
• Demonstrated experience of life science validation, audit requirements, including risk-based methodologies.
• Strong knowledge of global regulatory requirements of GMP, GCP, GLP, GDP and/or other domains.

Attributes

• Customer and results orientated personality.
• Role requires effective communication and team skills.
• Support, diagnostic and problem-solving skills experience.
• Flexibility in thinking/action and pragmatic in solving problems.
• Flexibility in role and approach, comfortable with adopting and adapting different roles as required.
• Fluency in English is essential. 

BENEFITS:

Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes:

• 3 weeks’ vacation plus floating holidays and sick leave
• 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions and profit sharing contribution equal to 4% of your eligible pay
• U.S. Employee Stock Purchase Plan- 15% Discount
• Comprehensive Medical, Dental, Vision, Life and Disability coverage
• Health, Dependent Care and Limited Purpose Flex Spending and HSA options
• Adoption assistance
• Tuition reimbursement
• Concierge/personal assistance services
• Voluntary benefits including Legal, Pet Insurance and Critical Illness coverage
• Gym, fitness facility and cell phone discounts

GUIDING PRINCIPLES:

Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.

COMPLIANCE OBLIGATIONS:

Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to:

Employee Obligations:

• Always act with honesty and integrity.
• Risk IQ: Know what policies apply to your role and function and adhere to them.
• Speak Up: If you see something, say something.

Manager Obligations:

• Always act with honesty and integrity
• Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation.
• Model and reinforce a Speak Up culture on your team.

The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined.  The employee may perform other functions that may be assigned.  Management retains the discretion to add or change the duties of this position at any time.

EQUAL EMPLOYMENT OPPORTUNITY

EOE/Minorities/Females/Vet/Disabled