Manager, Compliance Quality Assurance

Indivior•Raleigh, NC

1d•Onsite

About The Position

The Compliance Quality Assurance (CQA) Manager is responsible for leading and managing activities within the CQA team. The scope of responsibilities includes managing site Quality events within the eQuality Systems, ensuring site Compliance, Document Control, Annual Product Quality Reviews (APQR), Quality Technical Agreements, site self-inspections, and Bulk Product dispositions. This role will liaise with the Head of Quality Systems & OPEX to ensure that processes developed at the Raleigh site ensure a state of control and are compliant with regulatory requirements set forth in Indivior’s Quality Management System. The CQA Manager will support audits directed by the Global audit function and maintains the site in a constant state of inspection readiness. The CQA Manager will be expected to support the Head of Site Quality in regulatory site inspections. The CQA Manager prepares/reviews site Quality Metrics for management review and makes recommendations for continuous improvement.

Requirements

Bachelor of Science degree in a relevant scientific field required.
Minimum ten (10) years of experience in pharmaceutical manufacturing required.
Minimum five (5) years of progressive supervisory experience in pharmaceutical manufacturing required.
Prior Quality System Management experience.
In depth knowledge and experience with USP, CFR, ICH, and ISO regulations as well as current GMPs, regulatory requirements related to international standards including EU, Health Canada, TGA, ICH, PIC/S preferred.
Experience in a sterile manufacturing environment required.
Knowledge and understanding of regulatory requirements such as 21 CFR Part 210 and 211, Annex 1, cGMPs, and GDPs preferred.
Advanced computer skills, knowledgeable of data analysis, and statistical methods.
Successful implementation of continuous improvement opportunities.
Results oriented, entrepreneurial, and self-motivated, with solid planning and organizational capabilities, a bias for action, and the capability to define and evaluate risks.
Make and communicate appropriate judgments on any assessed risks to continue or suspend until risk can be mitigated.
Excellent communication both written and oral and problem-solving skills.
Strong analytical skills with the ability to think strategically, develop tactics and measurable implementation plans and able to transform solid thinking into action.
Proven ability to work under pressure without compromising deliverables.
Ability to collect, understand and interpret data trends on the quality system performance.
Strong computer skills including Microsoft platform and Visio.

Nice To Haves

Experience in VeevaVault preferred.
Combination Product experience a plus.
Knowledge of quality system methodologies, such as Failure Mode Effect Analysis, Pareto Analysis and understand Six Sigma principles.

Responsibilities

Supervise, develop, manage, and train direct reports in Quality Systems and Lot Release.
Effectively hire, coach, and motivate staff.
Write and administer performance appraisals for department personnel.
Develop, support, and sustain appropriate metrics including processing and preparing trend data for presentation to management during monthly and quarterly reviews.
Manage the APQR process and deliver approved reports on time per the approved schedule.
Manage the Document Management System; create, review, and approve documents including SOPs, WIs and protocols.
Manage periodic document reviews while meeting review dates.
Collaborate with the Global audit function to develop the annual supplier audit schedule and manage completion of audits against the schedule.
Manage the approved vendor/supplier site list for the site.
Establish annually the internal audit schedule and manage completion of the internal audits against the schedule.
Ensure the site maintains a constant state of inspection readiness.
Lead the back room during regulatory inspections and customer audits.
Act as back up to the inspection host.
Issue batch records to operations in support of the schedule.
Ensure timely disposition of semi-finished Drug Product.
Ability to conduct root cause analysis and risk assessments.
Review and approve non-conformances, CAPAs, and change controls related to the area of responsibility.
Ensure that the site and quality systems remain in compliance with changes to regulatory requirements.
Provide regulatory expertise to the technology transfer process, as needed.
Assure job objectives are met on a timely basis and escalate quality issues to the Site Head of Quality.
Proactively drive a culture of continuous improvement.
Communicate effectively/efficiently with others in a professional manner.
Manage a wide variety of tasks under critical time constraints.
Other activities as required.

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 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.