1 Head, Quality Operations, North America Job in Richmond, VA
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Head, Quality Operations, North America
$218k-299k (estimate)
Full Time | Pharmaceutical
1 Week Ago
Indivior is Hiring a Head, Quality Operations, North America Near Richmond, VA
TitleHead, Quality Operations, North America
Title: Head, Quality Operations, North America
Reports To: Vice President, Quality Management
Location: Richmond, VA, Raleigh NC or Fort Collins, CO
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 SummaryThe Head of Quality Operations, North America (NA), 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 Quality Management, this position manages the NA Quality Assurance team Product Quality Managers as well as focusing on Continuous Improvement. The Head must ensure that Drug Products manufactured at CMOs, packaged at CPOs and tested within NA are delivered into all regions, meet patient needs, are compliant with Marketing Authorisations and meet GxP requirements. The position is also key in helping to establish and sustain the global Pharmaceutical Quality System. Most importantly, the position helps to drive a ‘culture of quality’ at Indivior.
This individual will also liaise with the Head of EMEA Quality Operations, Global Quality Systems and OPEX, Head of Quality Operations, Raleigh, Head of Quality Operations Fine Chemical Plant and the Head of Audits to assist in the development of organizational strategies as a key member of the Quality Leadership Team.
Essential FunctionsThe responsibilities of this job include, but are not limited to, the following:
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
Title: Head, Quality Operations, North America
Reports To: Vice President, Quality Management
Location: Richmond, VA, Raleigh NC or Fort Collins, CO
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 SummaryThe Head of Quality Operations, North America (NA), 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 Quality Management, this position manages the NA Quality Assurance team Product Quality Managers as well as focusing on Continuous Improvement. The Head must ensure that Drug Products manufactured at CMOs, packaged at CPOs and tested within NA are delivered into all regions, meet patient needs, are compliant with Marketing Authorisations and meet GxP requirements. The position is also key in helping to establish and sustain the global Pharmaceutical Quality System. Most importantly, the position helps to drive a ‘culture of quality’ at Indivior.
This individual will also liaise with the Head of EMEA Quality Operations, Global Quality Systems and OPEX, Head of Quality Operations, Raleigh, Head of Quality Operations Fine Chemical Plant and the Head of Audits to assist in the development of organizational strategies as a key member of the Quality Leadership Team.
Essential FunctionsThe responsibilities of this job include, but are not limited to, the following:
- Ensures all functions in North American business understand their role in delivering Quality Patient Care.
- Commercial Quality Assurance activities for North American region including personnel.
- Commercial product release supporting patients’ markets supplied from North America region.
- Quality Assurance data base and documentation systems supporting North American commercial activities.
- QA activity into Computer Systems Validation for global applications.
- Transfer of NPD/EPD products into the commercial Pharmaceutical Quality System, PQS.
- Develop, maintain and trend the performance of the CMO, CPO and internal activities.
- Work and communicate with the Global Quality System and OPEX team relating to the global training requirements to ensure alignment.
- Participate in audits and inspections serving as the training subject matter expert specific to the site.
- Knowledge of and understand regulatory requirements such as 21CFR part 210 and 211, 820, Annex 1, cGMPs, FDA, TGA, HPRA, MHRA, OSHA and other regulatory agencies.
- Provides strategic and tactical level oversight for contracted quality operations in North America. Responsible for providing quality support to all regions/countries where NA manufactured product is distributed.
- 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 North American 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 EMEA and AuA Regions to ensure compliant, yet efficient release and disposition of drug products globally.
- Responsible for, 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.
- 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 North American Contractors and confirmation imported product meets US or territory requirements.
- Ensure on time completion of Annual Product Quality Reviews from CxOs and internal.
- QA approval of GxP processes in the North American Business as well as Global PV Operations processes.
- Responsible for managing Global QA oversight of GxP critical computer systems ensure computer systems validation meets business and competent authority expectations.
- Responsible for basic quality operational functions such as, but not limited to: investigations; product acceptance and release; product quality reviews; management reviews; CAPA/continuous improvements; documentation systems and like responsibilities.
- Reporting of key metrics (KPIs), periodic quality reports, and audits as needed.
- Technology transfer QA activities for NPD and EPD into commercial supply
- Management of GxP critical events and any North American recall.
- Management of Quality Data Base and Documentation applications for NA 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.
- 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.
- Minimum 15 years with a proven track record in the pharmaceutical, biopharma or biologics industries.
- Quality oversite of Sterile product manufacture is required.
- Proven track record in a direct leadership role.
- 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, drug substance and combination product regulatory requirements (e.g. EU GMP, WHO, PIC/S, CFR 21 Part 210/211, ICH Q7, CFR Part 820).
- Prior experience managing contract and/or outsourced organizations is required.
- Experience in hosting Competent Authority inspections and communicating with Competent Authority Inspectors and officials.
- Excellent organizational and multitasking capabilities and ability to work cross functionally across all levels of the organization.
- Knowledge of quality system methodologies, such as Failure Mode Effect Analysis, Pareto Analysis and understand Six Sigma concept.
- Working in compliant, yet efficient ways with the regional QPs to ensure effective export/import operations of drug product.
- 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.
- Approval of Technology Transfer of NPD/EPD products to ensure smooth introduction into commercial supply.
- Escalation of compliance and product risks to Quality Leadership Team and Senior Management.
- Management review of Quality and Quality objectives established within Indivior and with key contractors.
- Maintaining current working knowledge of regulations that impact on role.
- 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.
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
Job Summary
JOB TYPE
Full Time
INDUSTRY
Pharmaceutical
SALARY
$218k-299k (estimate)
POST DATE
06/20/2024
EXPIRATION DATE
07/18/2024
WEBSITE
indivior.com
HEADQUARTERS
FORT COLLINS, CO
SIZE
500 - 1,000
FOUNDED
2014
TYPE
Public
CEO
BRENT COONTS
REVENUE
<$5M
INDUSTRY
Pharmaceutical
Related Companies
About Indivior
Indivior is a Virginia-based pharmaceutical company that develops and commercializes buprenorphine-based prescription drugs for the treatment of opioid disorders.
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