Operations & Compliance Lead, EU

TITLE:

Operations & Compliance Lead, EU

Title:    Operations & Compliance Lead, EU

Reports To: Head of Global Logistics and Operations & Compliance EU

Location: UK – Slough

Direct Reports: 0

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 Operations & Compliance Lead, EU is a key position within Indivior supporting Supply Chain operations  focusing on compliance, network sustainability, agility and resilience.

The role is responsible for overseeing, supporting and managing supply chain and logistics strategy and operations in order to maximise the process efficiency, compliance, sustainability and productivity.

The role requires an in-depth understanding of the pharmaceutical Supply Chain and logistics operations and is responsible to ensure Indivior’s European warehousing and in market network will always be able to support the strategic vision of the company including a focus on short and long term launches and expansions.

ESSENTIAL FUNCTIONS:

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

• Design, develop and implement the operations function, combining existing activities with new strategic focus areas.
• Manage Indivior own inventory across the network, ensure all documentation is in place and any additional requirements specific to cold chain/narcotics are met.
• Manage  of a Third Party network across the Europe
• Responsible for cost management and financial performance of the European  network via the budgeting process. Monitoring and acting on any deviations as required.
• Ensure the structures, processes and procedures are in place to execute the effective flow of goods and services from supplier to customer.
• Evaluate internal and external operations and the extended supply chain to maximise the efficiency of all trade routes and drive agility.
• Drive positive Supplier Relationship Management and assessing capabilities
• Provide cross functional support, guidance and coaching in operational activities to ensure the needs of the patient are met.
• Ensure performance is visible and transparent, driving the use of relevant metrics and monitoring.
• Driving compliance through the supply chain in areas including, but not limited to, inventory, deviations, capa’s and change controls.
• Establish and deliver the partner performance review program and oversee all partner activities including service, cost, compliance and associated projects via agreed Key Performance Indicators (KPIs)
• Actively work on Business Continuity Planning (BCP) activities; collaborating with insurer and risk adviser. Ensure robust BCP in place with suppliers to protect business and comply with FM Global standards

KEY CHALLENGES:

• The 100% service expectation exceeds any standard service target.
• The 100% accuracy required in stock management, security and compliance due to the nature of the product being narcotics.
• The high complexity of markets to manage with different local regulations, laws and cultures
• Management of high number of parallel activities with high number of different contacts
• Remaining focused on Core deliverables in an environment with constantly changing priorities and tight timelines
• Delivering high quality developments when time, cost and service cannot be compromised
• Being flexible in your approach, “mucking in” and rolling up your sleeves to ensure that delivery is achieved on time.
• In market narcotic distribution across all market in the Europe within time sensitive parameters 

MINIMUM QUALIFICATIONS:

Education:      Graduate

Experience:

minimum 5 – 10 years of experience in a relevant supply chain or function of.

• GxP & Pharmaceutical Experience essential.
• Demonstrable leadership and self motivation experience essential
• Ability to demonstrate a strong compliance mindset and deviation management
• Proactive key stakeholder management
• Proven experience of navigating complex supply chains
• Demonstrable track record of achieving results.
• Any previous project management exposure would be a benefit
• SAP experience would be beneficial, but ERP experience is essential.
• Knowledge of narcotics and regulatory Pharma business processes.
• You will possess first class communication and presentation skills, with the ability to foster strong relationships with both internal and external contacts
• Proven record of continuous improvement within the supply chain and on cross functional projects.
• Proven record in leading and developing teams.
• Fluent in English
• Educated to Degree level

Travel: Occasional domestic and international

COMPETENCIES/CONDUCT:

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

• Strong communication skills
• Able to effectively influence senior management and functions to drive change and improvement
• Strong ability to review & see beyond the detail of the numbers and identify issues and opportunities in the business.
• Displays a high sense of urgency
• Flexibility in thinking and pragmatic problem-solving skills
• Desire to achieve and succeed in a fast-moving environment.
• Strong analytical skills – including commercial, financial acumen and budget management
• Ability to work collaborative cross many different stakeholders and functional silo
• Flexible to travel as required
• Tenacity and robustness
• The business language in Indivior is English.
• A self-motivated and highly flexible individual who is able to manage multiple tasks and priorities within a fast-paced, entrepreneurial environment.
• Knowledge in Pharmaceutical Supply Chain Good Manufacturing (GMP), Good Distribution Practices (GDP) and Good Clinical Practices (GCP) as relevant.
• Knowledge in narcotic controls within a supply chain
• Knowledge in sub-contracting requirements (GMP, GDP and GCP activities, as relevant)
• Knowledge in Quality Management Systems
• Knowledge in GMP, GDP and GCP purchasing requirements

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

• 25 days holiday plus public holidays
• Flexible working; core hours are 10am-3pm, and we offer up to 2 days working from home/ week for office based roles, as well as a flexible Friday programme, subject to completion of contractual hours.
• Paid Volunteer Time Off
• 10% company pension
• EAP service including Legal, Health and Wellbeing support
• Optional Health Insurance with BUPA
• Company Death in Service and Payment Protection Insurance
• 3 Celebratory days
• Access to platform for discounts on such as gym membership, shopping, holidays
• Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.

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