Supervisor, Quality Program Management

Supervisor, Quality Program ManagementBuild your future at Curia, where our work has the power to save lives.Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives.We proudly offer:Generous benefit options (eligible first day of employment)Paid training, vacation and holidays (vacation accrual begins on first day of employment)Career advancement opportunitiesEducation reimbursement401K program with matching contributionsLearning platformAnd more!The Quality Program Management Supervisor will oversee and guide the QA batch record review and product disposition team. The supervisor is responsible for fostering strong client quality relationships and ensuring the timely review and disposition of executed batch records (clinical, commercial, and media fills). This role works closely with cross-functional teams to monitor and support the stages of the batch disposition process, including manufacturing and quality reviews, to ensure deliverables are completed on schedule to meet supply commitments.

Key responsibilities include supporting the establishment, tracking, and improvement of batch record review and disposition cycle times.

The role also involves coordinating shipments with the warehouse, participating in critical DEV review meetings to provide quality input, and contributing to the preparation of weekly and monthly metrics for senior leadership. Additionally, the supervisor will assist with identifying and implementing process improvements and support other QA areas as assigned by QA management.Essential Duties and Responsibilities:Supervise and provide guidance to the QA batch record review and product disposition teamSupport client Quality relationships through effective communication and timely deliverablesReview and assist in the disposition of executed Batch Records (Clinical, Commercial, & Media Fills) and collaborate with cross-functional teams to address review commentsMaintain the record review planner to track and monitor the stages of the batch disposition process, including manufacturing and quality reviews and quality disposition processesSupport efforts to monitor and improve batch record review and disposition cycle timesAssist in tracking metrics for the review and disposition process and provide input for monthly performance analysisOversee Disposition timelines and support client calls related to Disposition schedules and delaysEnsure timely responses to client comments on Batch RecordsCoordinate with QC labs, external testing, and the deviations team to ensure all deliverables are completed on time to meet supply commitmentsCoordinate shipments with the Warehouse (including Q Ships & Release Shipments)Participate in critical DEV review meetings and provide quality input as neededContribute to the preparation and presentation of weekly and monthly metrics for leadershipAssist in developing batch record review training materials for Quality and Production teamsReview and provide input on SOPs related to the functional areaSupport internal, client, and regulatory audits for batch record reviewsIdentify process improvements and assist in their implementationProvide support in other QA areas as assigned by QA Management.Read/interpret SOPs to ensure complianceMaintain up to date trainingsOther duties as assignedEducation and Experience:Bachelor's degree in Science, Chemistry, Biology or related field of studyMinimum of three (3) years in Quality Assurance or Regulatory Compliance ManagementMinimum of two (2) years in a leadership roleMinimum of three (3) years in an aseptic/sterile product facility, preferredKnowledge in current regulations (21CFR, Annex 1 etc), preferredSupervisory Responsibilities:This role is responsible for leading and supporting a team, overseeing day-to-day operations, managing departmental goals, and ensuring adherence to organizational policies and procedures. This role also involves fostering a positive work environment, providing guidance and support to your team members, and evaluating performance to drive continuous improvement and achieve both departmental and organizational objectives.Language Skills:The ideal candidate should have the ability to read and interpret various documents. These documents include safety instructions, standard operating procedures, technical procedures, and governmental regulations. Additionally, the candidate should possess strong written and verbal communication skills. They should also possess effective presentation skills, enabling them to successfully present information and respond to questions from groups of managers, clients, customers, and the general public.Mathematical Skills:Proficient in executing arithmetic operations including addition, subtraction, multiplication, and division across various units of measurement, employing whole numbers, fractions, decimals, and percentages. Candidates must possess a strong grasp of algebraic and geometric principles.Reasoning Ability:Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.Computer Skills:The ideal candidate will possess a strong technical foundation and proven capability in effectively utilizing diverse software tools to streamline the organization's daily functions. Essential skills encompass adeptness in manufacturing and internet software, alongside proficiency in Microsoft Office tools including PowerPoint, Excel, Word, and Outlook.Other Skills and Abilities:Leads with integrity and respectProvides guidance, coaching, and mentorship to team membersDemonstrates business acumenFosters a collaborative and positive work environmentChampions changeCoaches and DevelopsPromotes a safe and healthy work environment by actively identifying and addressing potential hazards, following established safety protocols, participating in safety training programs, and fostering a culture of awareness and responsibility among team members.Demonstrates strong attention to detailOther Qualifications:Must pass a background checkMust pass a drug screenMay be required to pass Occupational Health ScreeningPhysical Demands:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.The essential physical demands will vary for each Curia position.All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses. Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each position's physical requirements. Certain roles may involve climbing and working at elevated heights as well.Work Environment:The work environment characteristics, described below, are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment.The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background.The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required. Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task at hand. The employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment.The warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials.Some positions may occasionally be exposed