Supervisor, Production

Indivior; Raleigh (NC); On-site; USD 88,000 - 100,000; Full time

Benefits offered by this job

Bonus program

401(k) match

Stock purchase plan

Medical, dental, vision

Tuition reimbursement

Paid time off

Job summary

Indivior is seeking a Supervisor, Production to lead safety, quality and performance of the prep, compounding and filling areas. You will ensure cGMP compliance, manage day-to-day operations, and develop SOPs to drive continuous improvement.

The role requires leadership, 5+ years in a regulated industry, strong analytical and problem-solving skills, and the ability to work in a fast-paced pharmaceutical environment.

Qualifications

• Leadership and supervisory experience in a regulated environment.
• Minimum five years in a regulated industry; three years supervisory experience preferred.
• Experience in cGMP manufacturing or clean room environments preferred.
• Ability to apply analytical reasoning and root cause analysis to problems.
• Strong math and calculation skills; proficient in computer usage.
• Ability to read and implement technical writing and SOPs in a fast-paced setting.

Responsibilities

• Oversee that cGMP comformance and continuous improvement systems are in place.
• Ensure timely and accurate documentation and closeout of batch records.
• Manage day-to-day operations of the prep, compounding and filling area.
• Develop and review SOPs for prep, compounding and filling.
• Drive continuous improvements in the operational area and monitor KPIs.
• Lead internal/external audits and present findings to auditors.

Skills

Leadership

Supervisory skills

cGMP manufacturing

Documentation & batch records

SOP development

Root cause analysis

KPI analysis

Problem solving

Computer skills

Audits

Tools

None

Job description

Supervisor, Production

Indivior is a global pharmaceutical company working to help change patients' lives by developing medicines to treat Opioid Use Disorder (OUD). Our vision is that all patients around the world will have access to evidence-based treatment for OUD, and we are dedicated to transforming OUD from a global human crisis to a recognized and treated chronic disease. Building on its global portfolio of OUD treatments, Indivior has an exploratory pipeline of products designed to expand its heritage in this category. Headquartered in the United States in Richmond, VA, Indivior employs approximately 800 individuals globally.

POSITION OVERVIEW

The supervisor, production role is responsible for safety, quality and performance of the prep, compounding and filling area.

HOW YOU'LL MAKE AN IMPACT

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

• Oversee that operational areas are in cGMP compliance, and responsible for establishing systems that support the continuous improvement of procedures in order to heighten quality.
• Ensures the timely and accurate documentation and closeout of batch records.
• Manage the day-to-day activities of the operational area.
• Develop and review SOPs pertaining to Prep, Compounding and Filling.
• Drive the continues improvement in operational area.

Trend and take appropriate actions to agreed KPI.

WHAT YOU'LL BRING

Minimum qualifications:

• Demonstrated leadership and supervisory skills.
• Minimum five (5 ) years of experience in a regulated industry.
• Minimum three (3) years related experience supervision is preferred.
• Experience in cGMP manufacturing or clean room production environment is preferred.
• Ability to apply analytical reasoning and root cause analysis to solve problems.
• Strong math and calculating skills.
• Computer skills.
• Ability to read, understand, interpret and implement technical writing and instruction as well as have exceptional abilities to problem solve in a fast-paced environment.

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

• Get certified on all the curriculums in the operational area to 1, understand the process and help to improve it. 2. Help to cover over breaks, vacancies etc.
• Lead cross functional teams to solve urgent production issues, implement improvements.
• Work with operational team to improve KPIs or other trend/task independently.
• Independently investigate pharmaceutical operations and facility nonconformances, identifying any deviations from standards. This includes clearly defining problems, collecting, and organizing existing data, comparing causes to facts, identifying probable root causes, conducting interviews and SME discussions, and determining the best solutions for improvement of manufacturing processes, standard operations procedures (SOPs) and supply chain business practices.
• Review supporting documentation including batch documentation, ancillary documentation, test results / CoAs, product specifications, training records, SOPs, calibration records, packaging and validation protocols, and other technical documents.
• Assist with deviation/CAPA investigation and understand the process so if needed be able to take over and finalize an investigation/CAPA.
• Assist with revision to SOPs pertaining as an SME in the operating area.
• Be the SME during internal/external audits, lead presentation and present to the auditing team.
• Lead Tier 1 meeting and participate in Tier 2 meeting.
• Build a self-sufficient team that can work independent and have very little overview.
• Cover for peer and manager if needed.

HOW WE INVEST IN OUR PEOPLE

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:

Pursuant to various state Fair Pay Acts, below is a summary of compensation elements for this role at the company. The following benefits are provided by Indivior, subject to eligibility requirements.

Starting Salary: $88,000-$100,000 USD

*Note actual salary is based on qualifications and experience

• Competitive PTO plus company closure from December 24th- January 1st
• 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
• 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

OUR SHARED RESPONSIBILITY FOR ETHICAL CONDUCT

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 behavior.

Employee Obligations:

• Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure
• 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:

• Have unquestionable ethics and integrity with the willingness to stand firm on these principles even under significant pressure
• 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.

EQUAL EMPLOYMENT OPPORTUNITY

EOE/Minorities/Females/Vet/Disabled are encouraged to apply!

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.