Senior CQA Specialist

TITLE:

Senior CQA Specialist

Title: Sr. CQA Specialist

Reports To: CQA Manager

Location: Raleigh, NC

Indivior is a global specialty pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses. The name is the blend of the words individual and endeavor, and the tagline “Focus on you” makes the company’s commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction and mental illness.

Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. 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. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. Building on its global portfolio of opioid use disorder treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category.

POSITION SUMMARY:

The Sr. Compliance Specialist supports the Quality and Compliance systems at the Raleigh facility. This role is responsible for the management of Change Control and CAPA records, the authoring of Quality Agreements and APQRs and the site self-inspection program. The Sr. Compliance Specialist will have a high level of interaction and influence within the site and is expected to drive improvements to the systems for which the role is responsible.

ESSENTIAL FUNCTIONS:

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

• Develop, implement, and maintain systems and procedures to ensure a high level of inspection readiness and regulatory compliance.
• Participate in multi-functional project teams as a Quality Compliance representative as directed by the CQA Manager or Site Quality Head.
• Develop and participate in compliance initiatives based on new regulations, guidance documents and industry standards. 
• Function as a change controller and CAPA manager for site records.
• Facilitate the compilation of data, and author the Annual Product Quality Review reports.
• Author Quality Agreements
• Create the self-inspection schedule, perform self-inspections, write audit reports, and follow up on observations and non-conformances. 
• Participate in customer and regulatory audits, as required.
• Participate in the review and approval of GMP documents including, but not limited to procedures, validation protocols, engineering documents and critical work orders.
• Manage vendor-initiated changes and vendor complaints.
• Responsible for compiling and reporting metrics related to site compliance.
• Perform QA review and approval of incoming materials in the ERP System, as required.
• Provide support and guidance to ensure GDocPs are applied throughout the Raleigh Site. 
• Track open records in eQMS to include Deviations, Environmental Excursions, OOS investigations, CAPAs, and Change Controls to closure. Design and implement action plans to ensure compliance with procedural requirements. 
• Drive compliance initiatives based on new regulations, guidance documents, industry standards and Indivior global procedures as they apply to the site.
• Perform lab data and audit trail review as needed. 

MINIMUM QUALIFICATIONS:

• Bachelor’s Degree with 3-5 years GMP/GXP Pharmaceutical experience. 
• Must have an in-depth knowledge of current GMP/GXP as well as FDA trends and guidelines.
• Must have experience reviewing and approving validation documents.
• Must have excellent technical writing skills and technical reviewer experience.
• Must be able to communicate effectively both verbally and in writing with all levels of employees on all aspects of compliance.
• In-depth knowledge of quality assurance terminology, methods, and compliance tools. 
• Computer skills required; experience with Veeva preferred.
• Experience reviewing lab data and audit trail data preferred.
• Must be organized, detailed, and have ability to handle multiple tasks at once and redirect focus based on company's needs. Must be adaptable to schedule changes, shifts in priority and cross-functional task alignment. 
• Proficient with problem-solving and risk mitigation. 
• Must be team focused, motivated and foster a positive and accepting environment. 

COMPETENCIES/CONDUCT:

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

• Knowledge of quality system methodologies, such as Failure Mode Effect Analysis, Pareto Analysis and understand Six Sigma concepts.
• Embrace Indivior core culture principles.
• Embrace the dynamics of team support, team collaboration and team success. 
• Celebrate the core wins of the organization and empower others to sustain a quality mindset. 
• Always have patient safety at the forefront in the efforts to provide safe and effective products to enhance and improve lives. 
• Celebrate and embrace diversity, equity, and inclusion. 

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