TITLE:
QC Analytical Manager

Title: QC Analytical Manager, Raleigh

Reports To: Sr. Manager, QC, Raleigh

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 and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder.

POSITION SUMMARY:

The Quality Control Analytical Laboratory Manager is responsible for the overall leadership and development of the QC Analytical Laboratory team. The selected candidate will provide technical expertise for method transfer activities, oversee the QC lab capability expansion and champion continuous improvement initiatives to ensure safety, compliance and efficiency all while maintaining the required testing for system, component, raw material and final product releases. This is a working manager role.

ESSENTIAL FUNCTIONS:

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

• Manage the implementation of the QC Analytical Laboratory capability expansion.


• Manage the hiring, training, performance, and development of QC Analytical personnel.


• Provide subject matter expertise for equipment and instrumentation operation and qualification.


• Provide subject matter expertise on method transfers.


• Manage the QC Analytical department to ensure compliant testing in a timely manner.


• Manage OOS, Complaints, Non-conformances, and investigations, ensuring implementation of appropriate corrective actions.


• Champion QC Analytical compliance improvement and lead continuous improvements in laboratory safety.


• Author, review, and/or approve SOPs, policies, methods, specifications. stability and technical reports.


• Collaborate with other Indivior sites' laboratories as well as manufacturing and technical development teams to provide product support.


• Identify and manage the adherence to QC Analytical testing key performance indicators.


• Provide monthly and quarterly trend reports to senior site management.


• Participate as a subject matter expert during customer and regulatory audits.


• Perform testing as required.


• Other duties as assigned.

License/Certifications: N/A

Travel: Less than 10% travel.

• Bachelor of Science degree, minimum, in a relevant scientific discipline.


• 10+ years of experience in a pharmaceutical Quality Control laboratory and 5+ years of experience in a supervisory role.


• Experience with analytical method transfers, equipment and instrumentation qualification is required.


• Complete understanding and application of the practices and standards for testing performed in QC Analytical laboratories as required by FDA, TGA, HPRA and MHRA.


• Working knowledge of Six Sigma and/or Lean manufacturing tools.


• Excellent communication and interpersonal skills.


• Proven ability to work under pressure without compromising deliverables.


• Ability to coach, mentor, influence change at all levels of the organization, manage conflict and prioritize deadlines.

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 concept.

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 discount 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 and Dependent Care Flex Spending options


• Adoption assistance


• Tuition reimbursement


• Leverage Concierge/personal assistance services


• Voluntary benefits including Legal, Pet Insurance and Auto/Home coverage


• Gym, fitness facility and cell phone discounts


• Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.

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.

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