Fresenius Medical Care Job - 33035870 | CareerArc
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Company: Fresenius Medical Care
Location: Waltham, MA
Career Level: Executive
Industries: Healthcare, Pharmaceutical, Biotech

Description

Job ID 19000MD2

Available Openings 1

PURPOSE AND SCOPE:

Provides Quality Systems (QS) management oversight for from origination through implementation, to personnel, processes, and systems in the FMC-RTG-LLC organization. Maintains quality systems requirements in alignment with government and corporate requirements. Ensures a compliant, effective, and efficient end-to-end process for Quality System Documentation, Training, CAPA, Post Market Surveillance, Risk Management, Design Control, and Systems Validation management. Ensures an Integrated Quality System and its effective use across the FMC-RTG –LLC organization.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

  • Provides strategic leadership of overall objectives through the application of thoughtful techniques in the communication of the company's mission and core values as a means to effect positive change and/or create organizational structure within Quality Systems in North America.
  • Leads operational efforts through subordinates to complete the administration of business processes and services to ensure the operations effective achievement of goals within the assigned business unit(s).
  • Directs and oversees the broad activities of the business unit(s) through the interpretation, application and implementation of company-wide policies and procedures relevant to the assigned functional area(s).
  • 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 the recommendation and implementation of current practices. Develops and manages budget for QMS group and ensure adherence.
  • Develops, deploys, and maintains the North American Quality System in accordance with applicable local ordinances, state statutes and Federal regulations, and other laws, including FDA 21 CFR, FDA QSR, ISO13485, Canadian Regulations, Mexican Regulations, etc., and company requirements.
  • Ensures QS and procedures for regulatory compliance are established and deployed. Periodically reviews the suitability and effectiveness of the quality system with executive management. Assesses and advises senior management concerning the Corporate Master Quality Plan. Interacts frequently with all levels of management and cross functions.
  • Builds a strong performing QS organization with a clear mission of supporting growth and compliance.
  • Develops and implements an effective Quality System Integration Management program. Assists each facility in the development of the site Quality (Integration) Plan. Assesses and reports progress of each plan. Oversees the development of an electronic QMS.
  • Develops, implement, and maintains an effective and compliant program in: Document Management for the entire product lifecycle (PLM), Monitoring and Trending, CAPA/NCE/FADF/Recall Execution, Risk Management, Systems Validation, Employee Training, Design Controls, Post Market Surveillance, Management Review
  • Ensures CAPA Review Board (CRB) and Field Action Determinations (FAD) are effectively documented and communicated to relevant functions. Ensures risk management files are utilized, updated, and kept current.
  • Ensures all systemic remediation from internal and external audits are promptly addressed.
  • Performs trend analysis of quality data associated with FMCNA-RTG products and recommend corrective/preventive actions for problem resolution. Analyzes processes, work operations, quality records, complaints, and other sources of data to identify existing and/or potential causes of failures. Where failures and potential failures are identified, investigates and assists in making recommendations necessary to correct and prevent recurrence.
  • Manages and leads all FDA, ISO, and Regulatory audit activities at Corporate.
  • Serves as a member of the RISE steering committee.
  • Interacts with all organizational levels to manage the business, having strong interactions with SVPs, Presidents, and possibly the CEO. Represents the organization to external customers; regularly interacting with executives and major customers.
  • 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; establishing and maintaining effective internal systems and controls to promote compliance.
  • Provides leadership, guidance, and coaching to all direct reports to maintain an engaged and productive workforce; partnering with Human Resources on employee relations issues. Provides technical guidance.
  • 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.
  • Assists 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.
  • Travel to FMCNA office locations is required (20%).

SUPERVISION:

  • Responsible for the direct supervision of various levels of Quality Systems staff.

EDUCATION:

  • Bachelor's Degree required in a scientific or engineering discipline; Advanced Degree preferred.

EXPERIENCE AND REQUIRED SKILLS:

  • Minimum 15+ years of experience establishing and maintaining quality systems in the pharmaceutical and/or medical device manufacturing industry; 5+ years of experience internal senior management role or 10+ years of external experience in senior management level role.
  • Exposure to Chemistry, Microbiology, and Biology a plus.
  • Strong knowledge of FDA QSR, CFRs, ISO13485, Canadian, Mexican, and device and drug regulatory requirements and of standard quality assurance practices for manufacturing operations such as the ISO 9001, ISO14971, etc.
  • Professional quality discipline certifications (CQE, CQA, CQM or RAB) desired.
  • Strong leadership competencies and capable of directing a staff of senior professionals/experts.
  • Demonstrated experience managing one or more departments.
  • 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.

See Management Representative (MR)/Alternate skill set matrix for unique skills that are required in addition to the general quality leadership skills noted in the core job description.

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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