Job Summary

Collaborates with the Quality Assurance Sr Director in ensuring the development, implementation and review of Quality Systems so that they are adequate and compliant. Assists QA Sr Director with oversight of daily activities, including major projects, QA and Operations teams support; validation activities; Regulatory inspections, Change Control, KPIs and Events Management.

Salary Range: $119,149-$160,000 + 14% annual bonus

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Responsibilities

Responsible for the administration of the Quality System for the PU as directed by the site head in accordance with US Operations and Corporate policies and procedures. Reviews, and approves quality system documentation such as standard operating procedures, validation documentation, and manufacturing discrepancy reports. Provides cGMP guidance to all departments engaged in the production of pharmaceutical products. Initiates and implements quality improvements, change control and continuous improvement efforts.
Supports batch disposition related activities, Right First-Time initiatives, and helps develop programs to encourage and support the relationship between operational efficiency and quality and compliance.
Performs review of root-cause analysis and other problem-solving activities to identify effective corrective and preventive actions and appropriate effectiveness measures.
Has authority to make decisions for the PU QA department in internal and external meetings on behalf of the Director.
Plans for resources and administrates budget, with regards to personnel, equipment, and facilities.
Directs investigations of product complaints and manufacturing discrepancies for PU manufactured products and ensures completion of appropriate documentation. Interacts with the Vigilance and Medical Affairs Department as needed.
Participates in Regulatory/FDA inspections and audits by providing information or expediting/obtaining information required by the inspectors/auditors. Schedules and conducts pre-inspection review of operations and follow-ups where corrective action is required.
Responsible for Gap Assessment review and approval, including those related to regulatory standards and changes.
Develops human resources to better accomplish and perform in their duties as professional quality manager, supervisors, and technicians.
Coordinates the preparation, review, and approval of the Annual Product Quality Reports and any established metrics/KPI.

Requirements

Bachelors in Science with a minimum of 8years work related experience including a minimum of 3 years as manager or above. Advanced degree strongly preferred.
Advanced familiarity with regulatory requirements (FDA, EU, PIC/s, ICH)
Advanced training or experience in cGMPs, GLPs, legal and ISO requirements.
Experience in Project Management and Quality Systems implementation.
Sense of urgency and flexibility in executing responsibilities
Proficient in computer skills
Excellent verbal and written communication skills
Attention to detail
Motivation and enthusiasm

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

","

Job Summary

Collaborates with the Quality Assurance Sr Director in ensuring the development, implementation and revi...","Associate Director, QA","Full Time",[109],["B","3014561341"],"Work at Fresenius Kabi USA, LLC","3 days ago","/jobs/3014561341-associate-director-qa","Grand Island, NY, United States","/jobs?keyword=Fresenius+Kabi+USA%2C+LLC","/jobs?location=Grand+Island%2C+NY%2C+United+States","/jobs?keyword=Associate+Director%2C+QA",{"_65":66,"_67":110,"_69":111,"_71":92,"_73":112},"Grand Island","Grand Island, NY, United States, 14072","14072",["D",1775599200000],"Fresenius Kabi","Quality Assurance Manager

Collaborates with the Quality Assurance Sr Director in ensuring the development, implementation and review of Quality Systems so that they are adequate and compliant. Assists QA Sr Director with oversight of daily activities, including major projects, QA and Operations teams support; validation activities; Regulatory inspections, Change Control, KPIs and Events Management.\nSalary Range: $119,149-$160,000 + 14% annual bonus. Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.\nResponsibilities

Responsible for the administration of the Quality System for the PU as directed by the site head in accordance with US Operations and Corporate policies and procedures.\nReviews, and approves quality system documentation such as standard operating procedures, validation documentation, and manufacturing discrepancy reports.\nProvides cGMP guidance to all departments engaged in the production of pharmaceutical products.\nInitiates and implements quality improvements, change control and continuous improvement efforts.\nSupports batch disposition related activities, Right First-Time initiatives, and helps develop programs to encourage and support the relationship between operational efficiency and quality and compliance.\nPerforms review of root-cause analysis and other problem-solving activities to identify effective corrective and preventive actions and appropriate effectiveness measures.\nHas authority to make decisions for the PU QA department in internal and external meetings on behalf of the Director.\nPlans for resources and administrates budget, with regards to personnel, equipment, and facilities.\nDirects investigations of product complaints and manufacturing discrepancies for PU manufactured products and ensures completion of appropriate documentation. Interacts with the Vigilance and Medical Affairs Department as needed.\nParticipates in Regulatory/FDA inspections and audits by providing information or expediting/obtaining information required by the inspectors/auditors. Schedules and conducts pre-inspection review of operations and follow-ups where corrective action is required.\nResponsible for Gap Assessment review and approval, including those related to regulatory standards and changes.\nDevelops human resources to better accomplish and perform in their duties as professional quality manager, supervisors, and technicians.\nCoordinates the preparation, review, and approval of the Annual Product Quality Reports and any established metrics/KPI.\nRequirements

Bachelors in Science with a minimum of 8 years work related experience including a minimum of 3 years as manager or above. Advanced degree strongly preferred.\nAdvanced familiarity with regulatory requirements (FDA, EU, PIC/s, ICH)\nAdvanced training or experience in cGMPs, GLPs, legal and ISO requirements.\nExperience in Project Management and Quality Systems implementation.\nSense of urgency and flexibility in executing responsibilities\nProficient in computer skills\nExcellent verbal and written communication skills\nAttention to detail\nMotivation and enthusiasm\nWe offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.\nFresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.\n","Quality Assurance Manager

Collaborates with the Quality Assurance Sr Director in ensuring the development, implementation and review of Qu...",[122],["B","3189749288"],"Work at Fresenius Kabi","/jobs/3189749288-associate-director-qa","/jobs?keyword=Fresenius+Kabi",{"_65":66,"_67":110,"_69":111,"_71":92,"_73":112},["D",1775599200000],"University of Tennessee","Associate Director of Operations

Market Range: 14\nHiring Salary: $6,123.04 - $8,572.25/Monthly\nJOB SUMMARY/ESSENTIAL JOB FUNCTIONS: The Associate Director of Operations provides supportive direction to the Facilities Department at UTHSC. This position will have direct responsibilities for Building Maintenance, Grounds Services, Custodial Services, Logistical Services, Physical Plant Stockroom, Auto shop, Plumbing, HVAC, and Boiler Maintenance. This position is classified as an Essential Services Employee. Essential Services Employees maintain business operations for UT Health Science Center, support the physical operations, and safety of campus. This role involves performing various operations and services essential to maintain critical infrastructure and ensuring continuous operations.\nResponsibilities

Directs projects (e.g., site repairs/construction, preventive maintenance, etc.) to ensure completion within established time frames, project design, and budget.\nAssists with planning and executing building construction or renovation. Develops Building Assessment teams to detect potential infrastructure problems and determine infrastructure improvements.\nCoordinates planning and organizing Custodial, Building Services, and Logistical Services; oversees specific craft areas of Facilities maintenance and operations of building, facilities, and building systems.\nServes as the central point of contact to develop and organize plans for organizing long-term and short-term maintenance programs and associated budgets.\nInspects new construction, repair work, projects, equipment, work orders, daily maintenance, and supplies.\nWorks with constituents across the University to elicit needs, address issues, plan work, etc.\nMonitors the financial activity to ensure expenses remain within budget limits and/or fiscal practices are followed.\nManages and ensures compliance with all local, state, and federal regulatory agencies.\nCreates and promotes pathways for maintenance team members to advance and grow professionally.\nIdentifies and implements best practices, policies, and procedures for maintenance teams.\nOversees human resources personnel functions to include interviewing, evaluating, supervising, recommending new hires, promotions, terminations, and transfers.\nCoordinates and schedules special event operations and safety training.\nParticipates in meetings, workshops, and seminars.\nPerforms other duties as assigned.\nQualifications

EDUCATION: Bachelor's Degree in Business Administration, Management, or other related fields. (MBA or Master's Degree in Management, Personnel Management, or Industrial and Systems Engineering is preferred.) (TRANSCRIPT REQUIRED)\nEXPERIENCE: Three (3) years of relevant, progressively responsible senior-level management experience in higher education, health care, or corporate facilities management; OR a combination of education and related work experience to equal seven (7) years. Must have a valid Driver's License.\nWORKING CONDITIONS: Ability to work in extreme cold/heat environments.\nKNOWLEDGE, SKILLS, AND ABILITIES:\nKnowledge of engineering and management principles.\nKnowledge of practices and concepts including facilities planning.\nKnowledge of design and construction.\nKnowledge of facilities maintenance management and energy management.\nAbility to oversee personnel management and training.\nSkilled in financial management.\nAbility to demonstrate excellent administrative skills.\nAbility to effectively supervise.\nWORK SCHEDULE: This position may frequently be required to work evenings and weekends. May require occasional overnight travel.\n","Associate Director of Operations

Market Range: 14\nHiring Salary: $6,123.04 - $8,572.25/Monthly\nJOB SUMMARY/ESSENTIAL JOB FUNCTIONS: The As...","Associate Director of Operations-Facilities Administration",[136],["B","3189782640"],"Work at University of Tennessee","/jobs/3189782640-associate-director-of-operations-facilities-administration","Memphis, TN, United States","/jobs?keyword=University+of+Tennessee","/jobs?location=Memphis%2C+TN%2C+United+States","/jobs?keyword=Associate+Director+of+Operations-Facilities+Administration",{"_65":66,"_67":137,"_69":138,"_71":139,"_73":140},"Memphis","Memphis, TN, United States, 37544","TN","37544",211,"name","Mansueto Ventures","agency","logo","https://production-rails-default.s3.us-east-2.amazonaws.com/public/legacy-logos/109473.JPG","slug","mansueto-ventures-careers","

Mansueto Ventures is home to two of the most iconic and vibrant brands in business publishing: Inc. and Fast Company. Every day, the content, awards, and events produced help entrepreneurs and innovators succeed by providing useful insights, sparking essential conversations, and offering much-needed inspiration.

Inc. is the voice of the American entrepreneur, inspiring and documenting the risk-takers and ultra-driven go-getters who represent the most dynamic force in the American economy.
Fast Company is the world’s leading business media brand, focusing on innovation in technology, leadership, and design to inspire readers to shape the future of business.

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