Director, Site Quality - Raleigh

About the role

The Director of Quality - Raleigh is a critical part of the global quality organization, and is both a strategic and tactical, hands-on role. This position reports into the VP, Quality Management and is accountable for the quality site organization and the staff that fulfills its regulatory responsibilities by ensuring that all Indivior activities and commercial products are compliant to Marketing Authorizations and cGxP requirements.

Responsibilities

• Manages and escalates quality and compliance issues to the VP, Quality Management; Director, Quality Ops and Raleigh Site Director, as applicable.
• Holds site-level accountability for sterility assurance, batch disposition, and patient safety in the highest-risk manufacturing environment, consistent with Director-level enterprise risk ownership.
• Acts as the primary site representative for FDA and global Health Authority inspections, commits the organization to remediation strategies, and owns critical compliance outcomes.
• Manages the performance of laboratory tests and examinations to established method and specifications.
• Approves or rejects components, APIs, raw materials or intermediates.
• Disposes the product for release to customer.
• Serves as the primary contact to regulatory authorities for site inspections, compliance questions, and ongoing communication.
• Interacts with relevant functions to assure appropriate systems are maintained and implemented for compliance to cGMPs.
• Ensures processes and products are in compliance to all local, state, federal, and international rules and regulations.
• Conducts periodic reviews for adequacy of policies and procedures to assist the business in the strengthening of the PQS and to meet current INDIVIOR and regulatory requirements.
• Manages internal and external documentation flow for QA activities including change management, deviations, laboratory investigations and non-conformances.
• Ensures quality incidents are fully investigated, root cause analysis is defined and that CAPA(s) are implemented and monitored for effectiveness.
• Ensures Quality Management Reviews are conducted periodically and report on the quality performance using KPI’s that measure QMS and regulatory compliance and drive improvement.
• Collaborates with Quality Validation and Quality Operations, participates in Technology Transfer activities into commercial supply as required.
• Manages cGxP critical events and any recalls/mock recalls conducted as per procedure.
• Manages stability studies, as applicable.

Requirements

• Bachelor of Science degree in a life science or engineering discipline.
• Postgraduate degree is preferred.
• Proven track record in a direct leadership role within pharmaceutical, biopharma or biologics industries with emphasis on sterile DP manufacture and testing.
• Evidence of successful history in Health Authority inspections and follow-up.
• Thorough understanding of regulatory requirements for the testing, manufacturing, and packaging of drug product, devices or combination products.
• Experience in product manufactured for the US, EU and Asia.
• 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 management of product quality complaints.
• Comprehensive understanding of key pharmaceutical and Quality Management processes, test method verifications/validations and manufacturing and packaging facility requirements is required.
• Practical demonstrated application of drug/combination product regulatory requirements (e.g. EU GMP, WHO, PIC/S, CFR 21 CFR Part 210/211, 21 CFR Part 4, 21 CFR 820); Clinical Trial Regulations (ICH E6, E2A, E8 and 21 CFR Part 50) and GLP Regulations (Directive 2004/9/EC 21 CFR 58).
• Prior experience managing contract and/or outsourced organizations is a definite plus.
• Experience in hosting Competent Authority inspections and communicating with Competent Authority Inspectors and officials.
• Strong analytical and problem-solving ability.
• Experience in managing Controlled Substances.
• 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 production operations is a plus.
• Influencing skills in areas with no direct reporting authority.
• Strong planning and organization skills.
• Auditing skills, and appropriate qualifications in auditing is an advantage.
• Motivated by delivering high quality patient treatments in the arena of addiction.
• Proficient in English. However, fluency in other languages is advantageous.

Qualifications

• 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 management of product quality complaints.
• Comprehensive understanding of key pharmaceutical and Quality Management processes, test method verifications/validations and manufacturing and packaging facility requirements is required.
• Practical demonstrated application of drug/combination product regulatory requirements (e.g. EU GMP, WHO, PIC/S, CFR 21 CFR Part 210/211, 21 CFR Part 4, 21 CFR 820); Clinical Trial Regulations (ICH E6, E2A, E8 and 21 CFR Part 50) and GLP Regulations (Directive 2004/9/EC 21 CFR 58).
• Prior experience managing contract and/or outsourced organizations is a definite plus.
• Experience in hosting Competent Authority inspections and communicating with Competent Authority Inspectors and officials.
• Strong analytical and problem-solving ability.
• Experience in managing Controlled Substances.
• 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 production operations is a plus.
• Influencing skills in areas with no direct reporting authority.
• Strong planning and organization skills.
• Auditing skills, and appropriate qualifications in auditing is an advantage.
• Motivated by delivering high quality patient treatments in the arena of addiction.
• Proficient in English. However, fluency in other languages is advantageous.

Skills

• Understanding of regulatory requirements for the testing, manufacturing, and packaging of drug product, devices or combination products.
• Experience in product manufactured for the US, EU and Asia.
• Comprehensive understanding of key pharmaceutical and Quality Management processes, test method verifications/validations and manufacturing and packaging facility requirements.
• Practical demonstrated application of drug/combination product regulatory requirements (e.g. EU GMP, WHO, PIC/S, CFR 21 CFR Part 210/211, 21 CFR Part 4, 21 CFR 820); Clinical Trial Regulations (ICH E6, E2A, E8 and 21 CFR Part 50) and GLP Regulations (Directive 2004/9/EC 21 CFR 58).
• Experience in hosting Competent Authority inspections and communicating with Competent Authority Inspectors and officials.
• Strong analytical and problem-solving ability.
• Experience in managing Controlled Substances.
• 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 production operations.
• Influencing skills in areas with no direct reporting authority.
• Strong planning and organization skills.
• Auditing skills, and appropriate qualifications in auditing.
• Motivated by delivering high quality patient treatments in the arena of addiction.
• Proficient in English. However, fluency in other languages is advantageous.

Benefits

Starting Salary: $200,000-$230,000 USD
Eligible to participate in Indivior’s bonus program, based on company and individual performance
Eligible to receive a yearly grant as part of Indivior’s Long-Term Incentive Plan
Competitive PTO plus company closure from December 24th- January 1st
401(k) and Profit-Sharing Plan- Company match
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
Wellness programs as well as other discounts and perks