Compliance Manager

Fresenius Medical Care; Waltham (MA); On-site; USD 109,000 - 183,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Paid time off and parental leave

Job summary

Fresenius Medical Care seeks a senior quality systems leader to manage and optimize our company quality programs across multiple sites. This role drives compliance with US FDA regulations and international quality standards, mentors staff, and partners with cross-functional teams to resolve complex quality issues.

Candidates should have 6–8 years in quality systems within medical devices or pharmaceuticals and proven supervision.

Qualifications

• Minimum 6–8 years of related quality systems experience in a medical device/pharmaceutical environment.
• 3+ years of supervisory experience preferred.
• Knowledge of US cGMP/QSR, ISO 13485, and related quality standards.

Responsibilities

• Directs tactical execution of quality systems objectives with oversight of results, costs, methods, and staffing.
• Leads, coaches, and develops direct reports in collaboration with HR.
• Oversees development and implementation of quality inspection/testing standards.

Skills

Regulatory knowledge

Attention to detail

Communication skills

Training/coaching

Project management

Cross-functional collaboration

Education

Bachelor's degree

Advanced degree desirable

Tools

Microsoft Office

Job description

PURPOSE AND SCOPE:

Develops, implements, and maintains the activities of company quality systems. Manages and oversees the activities of various levels of quality systems staff.

PRINCIPAL DUTIES AND RESPONSIBILITIES:

• Manages the tactical execution of short- and long-term quality systems objectives through the coordination of activities with a direct responsibility for results, including costs, methods, and staffing.
• Provides leadership, coaching, and development plans for all direct reports to maintain an engaged and productive workforce; partnering with Human Resources on employee matters. Provides technical guidance.
• Technically proficient in the specific quality systems department and knowledgeable of industry practice and business principles. Works on issues of diverse scope where analysis of situation or data requires evaluation of a variety of factors, including an understanding of current business trends.
• Oversees development and implementation of standards, methods, and procedures for inspecting, testing, and evaluating the precision, accuracy, and reliability of company products.
• Makes recommendations for corrective action necessary to ensure conformity with quality specifications. Ensures finished products conform to government and company standards and satisfy good manufacturing practices regulations. Selects, develops and evaluates personnel to ensure the efficient operation of the function.
• Collaborates with internal and/or external resources to resolve problems of medium to high complexity in Quality issues.
• May report quality metrics to senior/executive management, as needed.
• In some locations/sites, may have the authority to issue a STOP NOTICE to immediately stop production when a concern regarding possible productions, stocking, or shipping of discrepant assemblies or product arises.
• Represents functional expertise at relevant department and site meetings, as needed.
• Follows processes and operational policies in selecting methods and techniques for obtaining solutions. Interprets and recommends change to policies and establishes procedures that effect immediate organization(s).
• Makes recommendations for process improvements and participates in planning and implementing changes.
• Frequently interacts with subordinate supervisors, customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers.
• Interacts with internal departments and external customers; particularly in problem resolution. Acts as an advisor to subordinate(s) to meet schedules and/or resolve technical problems. Responsible for hiring, coaching and counseling employees, including performance reviews, disciplinary action and terminations.
• 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.
• Works in an office environment and may be required to perform light lifting. This position involves sitting and or walking for considerable lengths of time. Bending to floor level is required.
• Travel up to 10% of the time required with the potential for additional travel, as needed.

SUPERVISION:

Responsible for the direct supervision of various levels of quality systems staff.

EDUCATION

Bachelor's Degree required, preferably in a scientific or engineering discipline; Advanced Degree desirable.

EXPERIENCE AND REQUIRED SKILLS:

• Minimum 6 - 8 years of related quality systems experience in a medical device/pharmaceutical environment.
• 3+ years of supervisory experience preferred.
• Must be proficient with personal computer; strong skills with Microsoft Office software.
• Knowledge in relevant federal regulatory requirements.
• Strong attention to detail. Ability to drive results.
• Ability to train technical, professional, and managerial level personnel.
• Excellent verbal and written communication and strong interpersonal skills.
• Requires ability to function effectively in multiple team settings as well as independently and to manage multiple priorities.
• Knowledge of US cGMP/QSR, ISO 13485, and related Quality standards.
• Strong knowledge of FDA regulatory requirements and of standard quality assurance practices for manufacturing operations.
• As applicable, strong knowledge of Health Canada GMPs.
• Remains current with industry standards and best practices.

The rate of pay for this position will depend on the successful candidate’s work location and qualifications, including relevant education, work experience, skills, and competencies.

Annual Rate: $109,000.00 - $183,000.00

Non-Bonus Eligible Positions: include language below.

• Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave.

Bonus Eligible Positions – include language below.

• Benefit Overview: This position offers a comprehensive benefits package including medical, dental, and vision insurance, a 401(k) with company match, paid time off, parental leave and potential for performance-based bonuses depending on company and individual performance.

Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws.