Job ID 20000H1Q
Available Openings 1
PURPOSE AND SCOPE:
Directs and monitors the Quality System programs across the assigned manufacturing location. Assures compliance to all Country, Federal, State and local regulations regarding the manufacture and distribution of Medical Devices and/or Drug products. Establishes and standardizes Quality System procedures within the site and assures compliance. Reports key Quality Metrics and trends for manufacturing locations.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Provides strategic leadership of short- and long-term goals through the use of thoughtful techniques in the communication of the company's mission and core values as a means to implement positive change and/or create organizational structure within the assigned business unit(s).
Serves as official management representative for all regulatory matters and primary site leader for quality system issues.
Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
Ensures all employees within the assigned team(s) understand and comply with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
Ensures Quality System and programs are effectively established and maintained according to local, corporate and applicable state, federal and international requirements. Assures products achieve acceptable quality levels.
Assures the development, establishment and maintenance of a robust Quality System for the assigned plant that, complies with all country, federal and state regulations, and European or International Quality Standards, as required.
Standardizes/harmonizes policies and laboratory procedures, where appropriate, to ensure consistency between the plant, Corporate and other FMCNA Plants.
Investigates, assesses and implements new technologies to improve outputs for Quality, Safety, cost, efficiency reliability and accuracy.
Ensures that budgets and schedules are within company requirements with significant organizational responsibility for the overall control of planning, staffing, budgeting, expense priority management, and recommendation and implementation changes of current methods.
Establishes systems to monitor the quality initiatives and laboratory outputs for cost and efficiency. Reviews capital expenditure requests for Quality impact and appropriateness.
Assures timely and appropriate investigation, communication, disposition and corrective actions associated with product and/or process quality issues.
Assures timely and accurate presentation of key Quality performance metrics to plant personnel and Executive Management. Assess adequacy of overall Quality Function including resources and deployment.
Collaborates with employees in the establishment of clear and concise development plans to ensure succession planning and the advancement of future leaders within the organization.
Reviews, standardizes and harmonizes Quality policies, guidelines and procedures for both the plant and its suppliers. Insures compliance with cGMP, regulatory guidance and recognized standards, where appropriate.
Interacts with all levels within the organization to manage functional area. Overall responsibility for hiring, coaching and counseling employees, including performance reviews, disciplinary action and terminations.
Provide technical guidance.
Assist with various projects as assigned.
- Other duties as assigned.
Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
- The physical demands and work environment characteristics described here 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.
- Regularly required to talk or hear. Frequently required to stand; walk; sit and use hands to finger, handle, or feel. Occasionally required to reach with hands and arms.
- Must occasionally lift and/or move up to 25 pounds.
- The work environment is similar to that of any pharmaceutical/medical device manufacturer and would have no impact on the employee to perform the essential functions of this Job.
- The noise level in the work environment is usually moderate.
- May be responsible for the direct supervision of various levels of Quality Systems staff.
- Bachelor's Degree in a Scientific or Engineering discipline, with applied knowledge in Statistics, Chemistry, Microbiology and Biology required; Advanced Degree preferred
EXPERIENCE AND REQUIRED SKILLS:
- 10+ years' related experience.
- 5+ years' experience as a Manager; or 5+ years' experience in a senior managerial role.
- Strong management skills with the ability to lead cohesive and productive teams.
- Strong interpersonal skills with the ability to communicate with all levels of management through diplomacy and tact.
- Excellent oral and written communication skills.
- Strong knowledge of FDA regulatory requirements (cGMP/QSR) and of standard quality assurance practices for medical manufacturing operations.
- Experience with liquid filling and/or aseptic filling and microbiological/environmental control.
- Professional quality discipline certifications (CQE, CQA, CQM or RAB) desired.
- Ability to read, analyze and interpret blueprints, technical manuals, specifications, test methods and procedures/equipment manuals.
- Strong oral and written communication skills.
- Proficient with PCs and Microsoft Office applications.
EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity
Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.
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