Manager, Quality R&D Operations

TITLE:

Manager, Quality R&D Operations

Title: Manager, Quality R&D Operations

Reports To: Head, Global Quality Validation and R&D

Location: Fort Collins, CO

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 Manager, Quality R&D Operations will lead a team accountable for the quality systems necessary for the development and delivery of investigational medicinal products in R&D, in compliance with Indivior policies and procedures. This role is responsible for the release and supply of IMP in support of phase I-III clinical studies in the US and globally. The manager will review and approve documentation that support the QC laboratory operations at the Fort Collins site. The manager will provide leadership to adhere to the to the Fort Collins quality management system. The manager will provide good clinical practice (GCP) program support to the business.

ESSENTIAL FUNCTIONS:

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

• Lead a cohesive motivated and professional team within a results-orientated culture, where personal responsibility and collaboration are key.
• Manage a team accountable for maintaining the Fort Collins R&D and laboratory Quality System.
• Host regulatory inspections as required by competent authorities including FDA and DEA.
• Ensure that IMPs for clinical trials comply with cGMPs and Indivior approved procedures.
• Interact regularly and collaboratively with cross-functional teams to resolve all GxP related issues effectively including discrepancy investigations, CAPAs, change controls, key process development activities, and continuous improvement process reports.
• Ensures the drug substance and drug product can be sustainably manufactured through applying Quality by Design (QbD) principles and techniques.
• Release IMPs for use in clinical trials.
• Lead site Quality Management Reviews according to schedule.
• Ensure that site staff within R&D are trained in quality systems and procedures.
• Review and approve laboratory investigations and laboratory certificates of analysis.
• Maintains the Quality Assurance Function, to ensure that products are developed in a compliant and safe manner, and by stated timelines through established processes that are efficient and standardized.
• Provide advice on current inspection trends from Competent Authority information sources.
• In collaboration with the Indivior Quality Audit function, ensures approval of INDIVIOR IMP Contractors responsible for raw materials, API, manufacture, packaging, testing, distribution, and cGxP critical Service Providers.
• Ensure quality incidents are fully investigated, root cause analysis is defined and that CAPA has been implemented and monitored for effectiveness.
• Review and approve Indivior quality and clinical policies and SOPs.
• Approve and maintain R&D quality technical agreements.

MINIMUM QUALIFICATIONS:

• Bachelor of Science degree in a chemistry, pharmaceutical, life science or engineering discipline. Post graduate degree is preferred. Minimum 8 years’ experience in Quality Assurance and Quality Control in a regulated GxP environment.
• Proven record of accomplishment in Pharmaceutical, Biologics or Medical Device industries in a GxP, GCP, QC, or R&D environment.
• Thorough understanding of regulatory requirements for the development, testing, and manufacturing of a drug product.
• Experience in hosting or supporting regulatory inspections for the US FDA, EU, and other agencies.
• Knowledge of 21 CFR part 210/211, ICH Q8, ICH Q9 and ICH E6 standards and application of requirements.
• Direct experience in tech transferring API and drug products from development through clinical phases and successful hand off to commercial team for launch.
• Clear understanding of cGxP requirements and ability to assess and act upon product safety, quality, efficacy, and compliance risks, for both drug and combination products including Quality oversite of clinical trial conduct and management of product complaints.
• Risk evaluation and mitigation strategy (REMS) program experience a plus.

COMPETENCIES/CONDUCT:

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

• Strong interpersonal skills and ability to communicate clearly to all levels of the business, via concise written or oral summaries to senior management.
• Experience in management, quality programs, and production operations a plus.
• Proven people leadership experience with the ability to think strategically and coach and develop direct and indirect reports to contribute to the highest performance level.
• Strong planning and organisation skills.
• Auditing skills, appropriate qualifications in auditing are an advantage.
• Motivated by delivering high quality patient treatments in the arena of addiction.
• Proficient in English. However, fluency in other languages is advantageous.

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

SALARY RANGE:

$125,000.00 - 140,000.00 USD Annual

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