TITLE:

Supervisor, Environmental Monitoring

WHO WE ARE

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 Environmental Monitoring (EM) Supervisor is responsible for supervising the activities of Environmental Monitoring technicians and ensuring EM production coverage on all shifts is provided. Responsible for effectively hiring, developing, coaching, counseling, managing and motivating the EM staff. The number of direct reports fluctuates with the needs of the business. Responsible for the timely and accurate completion of required environmental samples and collection of water and other site utility samples.

Assures compliance to cGMP and Indivior specifications. Identifies areas for validation and/or improvement and develops protocols for same. Inform Senior Manager of QC of departmental activities and product related events. This position may represent the QC department at meetings and provides guidance in the absence of the Senior Manager of QC.

HOW YOU’LL MAKE AN IMPACT

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

Supervises daily activities of EM technicians. Assures that job activity deadlines are met on a timely basis. Ensures daily quality concerns and questions are being adequately addressed by department personnel.
Ensures system for monitoring and trending environmental data is up to date and data is approved
Assures proper and timely collection of environmental and site utility samples
Participates and serves as the EM representative during internal and regulatory audits
Creates EM summary reports to support site and product filings
Instructs the new employee gowning classes
Instructs the Aseptic Process Area (APA) gowning class and approves new employees to start APA qualification
Ensures all employees that enter the APA are gown qualified / requalified and participate in annual media fills
Assess planned repair work to be performed in the classified areas and completes the QC Approval of CWOs for the work to be performed
Ensures the review and approval of EM data is completed and delivered to MQA to support the weekly System Release process
Hires and oversees the training of department personnel. Assures steps are being taken to maintain positive personnel morale and development. Conducts performance evaluations
Assures execution of monitoring and testing programs to assess the microbiology quality parameters of in-process, environmental systems and effectiveness of production processes
Establishes goals for the timely release of product and performance of projects. Monitors performance of the group against the goals to identify and implement needed corrective action.
Ensures that product or an environmental system not meeting specifications and limits is promptly investigated
Identifies possible source and corrective action needed and evaluates the impact upon the lot
Identifies significant adverse quality trends by preparing and analyzing summary reports
Addresses quality control test results, microbial profiles of environmental systems.
Generates and updates Standard Operating Procedures
Maintains current knowledge of cGMPs and regulatory issues/guidelines
Assures department is equipped with functional, calibrated equipment and necessary supplies
Supervises investigations of out of specification results and environmental excursions
Ensures adequate evaluation of new product processes
Represents the department in cross functional teams and meetings
Performs other duties and projects as assigned by management

WHAT YOU’LL BRING

Bachelor’s degree in microbiology, biological sciences or related field required
Requires three to five years of progressive laboratory/environmental monitoring responsibility in support of pharmaceutical manufacturing or equivalent related industrial or clinical experience
Experience in aseptic processing is preferred
Must be knowledgeable of quality control testing methods, validation techniques and concepts of microbiology
Must be able to understand and scientifically interpret data utilizing analytical skills and practical experience in pharmaceutical applications
Supervisory experience preferred, but candidate must have held some type of leadership role
Demonstrated leadership and supervisory skills
Excellent verbal and written communication skills are essential

PHYSICAL REQUIREMENTS

Position is exposed to a number of environments, office, lab, outside, plant floor, etc. The role requires continuous computer use and typing, along with routine walking between offices, laboratories, and operational areas. Frequently talking and using eye and hand coordination. Occasionally requiring lifting and carrying less than 10 lbs. Standing, walking, bending over, and repetitive use of legs are done occasionally. Personnel engaged in the manufacture, processing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.

HOW WE INVEST IN OUR PEOPLE

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-$95,731 USD

*Note actual salary is based on qualifications and experience

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:

Competitive PTO plus company closure from December 24th- January 1st
Eligible to participate in Indivior’s bonus program, based on company and individual performance

401(k) and Profit-Sharing Plan: Company match of 75% on your first 6% of contributions and profit-sharing contribution equal to 4% of your eligible pay
Annual Equity for All program and 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.

Want to learn more? Connect with us at www.indivior.com or follow us at www.linkedin.com/company/Indivior.

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Supervisor, Environmental Monitoring