Job description
TITLE:
Product Quality Lead - Steriles
Title: Product Quality Lead, Steriles
Reports To: Product Quality Manager
Location: Remote role with minimum 50% on site assignment at CMO (Burlington, MA)
Indivior is a global specialty pharmaceutical company with a 20-year legacy of leadership in patient advocacy, health policy and evidence-based best practice models that have revolutionized modern addiction treatment. 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 – a chronic relapsing disease.
Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. The company has a strong pipeline of products and candidates designed to both expand on its heritage in global opioid dependence and address other chronic diseases of addiction – including opiate overdose, alcohol use disorders and cocaine intoxication - as well as related mental health disorders such as schizophrenia.
POSITION SUMMARY:
This role is responsible to support the assigned CMOs in their ability to successfully improve operations, manufacture Indivior batches, reduce lead times and increase capacity. To ensure that all the relevant process raw materials, intermediates and final products are manufactured, packaged, tested and released in full compliance with cGMP and regulatory requirements that meet the defined quality standards for the US and Most of World.
ESSENTIAL FUNCTIONS:
The responsibilities of this job include, but are not limited to, the following:
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Provide direct INDV QA on the floor (no cleanroom requirements) assistance for the resolution of quality minor deviations, escalations, and material disposition.
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Provide final INDV review of formulation, manufacturing, bulk packaging, and inspection records to ensure GMP completeness, accuracy and legibility.
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Provide direct support to the Indivior Product Quality Engineer for all related continuous improvement activities as applicable.
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Assist in providing direction in batch disposition, along with major deviations.
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Assist in providing support in internal audit activities for GMP compliance and to identify and raise GMP issues as or if they arise.
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Assist in providing daily walk throughs of operational work areas and review of processes to ensure GMP acceptability, cleanliness, organization and state of control.
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Assist Indivior Quality Validation Manager in providing support in change management and validation activities that may impact product and/or process.
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Assist in providing support for all changes and additions to SOP, Work Instruction, specifications and like documents.
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Work directly with CMO to gather and report Quality monthly metrics.
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Assist in providing training support for new and existing employees.
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Ensure that Annual Product Reviews have been completed by responsible parties and have been assessed internally against requirements and are delivered according to schedule.
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Ensure that the applicable Quality Technical Agreement requirements are being met.
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Participate in the review, investigations and responses for product quality complaints.
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Any other duties as determined by management to support North America Quality team.
MINIMUM QUALIFICATIONS:
Travel: Remote role with minimum 50% on site assignment at CMO (Burlington, MA)
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Bachelor of Science degree, minimum, in a relevant scientific discipline.
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Broad Knowledge of sterile manufacturing.
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Proven track record, 5+ years of quality experience, in a regulated industry such as FDA, pharmaceutical or medical device.
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Broad knowledge of current GMPs, regulatory requirements related to international standards including EU, Health Canada, TGA, ICH, PIC/S.
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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.
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Strong analytical skills with the ability to think strategically, develop tactics and measurable implementation plans and able to transform solid thinking into action.
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Excellent communication skills - presentation, written and oral.
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Proven ability to work under pressure without compromising deliverables.
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Collects, understands, interprets and trends data on the quality system performance.
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Strong computer skills including Microsoft platform and Visio.
COMPETENCIES/CONDUCT:
In addition to the minimum qualifications, the employee will demonstrate:
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Proficiency in conducting Risk Assessments to support deviation investigations, change management and CAPA.
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
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3 weeks’ vacation plus floating holidays and sick leave
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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
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U.S. Employee Stock Purchase Plan- 15% Discount
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Comprehensive Medical, Dental, Vision, Life and Disability coverage
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Health and Dependent Care Flex Spending options
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Adoption assistance
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Tuition reimbursement
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Leverage Concierge/personal assistance services
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Voluntary benefits including Legal, Pet Insurance and Auto/Home coverage
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Gym, fitness facility and cell phone discounts
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Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.
GUIDING PRINCIPLES:
Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.
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
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