TITLE:
Sr Director, Quality Operations, EMEA & API Manufacturing
Reports To: VP, Quality Management
Location: Slough, UK
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.
POSITION SUMMARY:
The Sr. Director of Quality Operations EMEA & API Manufacturing is a critical part of the global quality organization, and is both a strategic and tactical, hands-on role. Reporting to the Vice President of Global Quality, this position has overall responsibility for EMEA compliance, Fine Chemical Plant (FCP) Quality performance and EMEA Quality Operations performance. This role will build relationships and manage interfaces with supporting organisations (CM’s, Services providers, Regulatory, Medical, CMC, NA Quality etc) and organisations supported by EMEA Quality (Commercial EUCAN, Supply Chain etc.) including improved ways of working.
ESSENTIAL FUNCTIONS:
* Ensures all functions in EMEA business understand their role in delivering Quality Patient Care.
* Working with Supply Chain to determine batch disposition priorities to minimize patient impact.
* Commercial Quality Assurance activities for EMEA region including personnel and budget.
* Ensures all API Manufacturing activities at the FCP maintain compliance with stated regulatory, environmental, and Indivior internal requirements.
* Commercial product QP release supporting patients’ markets supplied from EMEA and North America region.
* Quality Assurance data base and documentation systems supporting EMEA commercial activities.
* Tech Transfer of products into the commercial Pharmaceutical Quality System, PQS, as applicable.
* Provides strategic and tactical level oversight for quality operations in EMEA and FCP API Manufacturing and Testing.
* Ensures all facilities and contract manufacturers operate in a state of quality compliance to ensure all product that is manufactured is safe, efficacious and effective for intended patient treatment.
* Develops and leads the EMEA quality team to ensure proper roles and responsibilities; development of personnel; establishment of succession planning; and, to ensure collaboration across all supported functions.
* Integrates quality oversight and operations effectively with NA and AuA Regions to ensure compliant, yet efficient release and disposition of drug products globally.
* Responsible for effective budget planning, driving costs of quality, and identifying continuous improvement opportunities within the supply chain and quality system.
* Maintenance and development of Area and local Indivior Pharmaceutical Quality System (procedures and working practices) to meet Indivior and Competent authority requirements.
* Leads diligence and compliance support for new product market entries.
* Key member of the Quality Leadership Team (QLT).
* Escalation of product and process quality issues and identified risks to the QLT and Supply Leadership Team (SLT) and Indivior Quality Council (IQC) as appropriate.
* Accountable for ensuring Launch and Annual Product Stability programs and the release of Finished Product from EMEA Contractors and confirmation imported product meets EMEA or territory requirements.
* Management of GxP critical events and any EMEA recall.
* Management of Quality Data Base and Documentation applications for EMEA to ensure compliant delivery of master instruction documents, Change Control, Risk Management, Deviation, Investigation and CAPA systems activities.
* Management of Product Complaints.
* Hosting key regulatory inspections and supporting at key suppliers for the same.
* Establishing and sustaining a culture of quality at Indivior and all key suppliers.
* PQS meets regulatory authority expectations to ensure continued support of all licences and certifications related to commercial GxP activity.
* Quality essential training delivered to correct job roles and competency confirmed to ensure patient supply, compliant and effective activity within the PQS.
* Escalation of compliance and product risks to EMEA Leadership Team and Senior Management.
MINIMUM QUALIFICATIONS:
* Bachelor of Science degree in a life science or engineering.
* Post-graduate and/or Professional Qualification related to Pharmaceutical or other related Quality Assurance skills is an advantage.
* Proven track record in the pharmaceutical, biopharma or biologics industries.
* Proven track record in a direct leadership role.
* Expertise managing geographically distributed teams.
* Clear understanding and ability to assess and act upon product safety, quality, efficacy and compliance risks.
* A proven track record with experience working in a quality and or regulatory compliance function in Healthcare, Pharmaceutical, or Medical Device related industry.
* Solid understanding of finished drug product and drug substance regulatory requirements (e.g. EU GMP, WHO, PIC/S, CFR 21 Part 210/211, ICH Q7, Annex 1).
* Experience in hosting Competent Authority inspections and communicating with Competent Authority Inspectors and officials.
* Intermediate competency in sterile manufacture, proficient in Annex 1.
* Advanced competency in tablet manufacture, investigation and change control management, root cause analysis.
* Intermediate (advanced preferred) in PowerPoint and Excel.
COMPETENCIES/CONDUCT:
* Strong interpersonal and communication skills and ability to communicate clearly to all levels of the business.
* Executive presence for giving presentations and updates is helpful.
* Influencing skills in areas with no direct reporting authority.
* Strong planning and organisation skills.
* Auditing skills, appropriate qualifications in auditing an advantage.
* Motivated by delivering high quality patient treatments in the arena of Addiction.
* Proficient in English. However, fluency in other languages is advantageous.
* Expected Travel- 20-40% (mainly to Ireland and France).
BENEFITS:
* 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.
* 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.
EQUAL EMPLOYMENT OPPORTUNITY
EOE/Minorities/Females/Vet/Disabled
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