Senior Compliance Specialist

Location

Massachusetts | United States

Job description

When you’re part of the team at Thermo Fisher Scientific, you’ll do meaningful work, that makes a positive impact on a global scale! Join over 100,000 colleagues who bring our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. You’ll find the resources here to achieve your career goals and help take science a step beyond by developing solutions for some of the world’s toughest challenges. This includes protecting the environment, making sure our food is safe, and helping find cures for cancer.

The Senior Compliance Specialist is responsible for ensuring the Organization’s compliance profile meets global governmental regulatory requirements, corporate policies, group and divisional processes as well as site-level procedures.  The goal of the Corporate Quality Audit Program is to identify and highlight compliance gaps, assess remediation needs and improvement opportunities across all of its sites and operations for management to ensure that appropriate and timely action can be taken to reduce the overall risk to the company.  The program accomplishes this through a methodical, collaborative and organized process driven by exceptionally qualified staff.  The Corporate Audit Program focuses on all operations (manufacturing, logistics and commercial) that could impact Thermo Fisher Scientific’s brand, market reputation, patients, consumers and customers.

What Will You Do? How Will You Make an Impact?

• Conduct audits, gap assessments and other related projects to evaluate the state of quality and regulatory compliance to quality management systems, product documentation and production processes per applicable quality and regulatory requirements, including but not limited to the US FDA CFR, European Medical Device Directives (MDD, IVDD, AIMD) and European Regulations (MDR, IVDR), Medical Device Single Audit Program (MDSAP), and international quality system standards (e.g. ISO 9001, 13485).
• Identify compliance gaps and assess the sites’ quality and compliance with corporate policies, site procedures, and all applicable regulatory expectations and regulations through the execution of a risk-based corporate audit schedule.
• Perform audit-related tasks, such as scheduling, reviewing technical documentation, assessing corrective action responses and providing feedback, preparing detailed audit reports and other audit documentation.
• Coordinate with stakeholders to manage audit projects by developing, maintaining, and executing audit plans.
• Monitor, evaluate, and determine the effectiveness of corrective and/or preventive actions.
• Analyze audit data, identify systemic compliance issues or gaps, trends, and recommend risk mitigation strategies to elevate the robustness of the quality management systems across the network.
• Provide accurate ongoing assessment by measuring compliance risks by monitoring, tracking and generating detailed trending reports and audit metrics.
• Utilize change order process to improve and update policies, procedures, work instructions, and templates.
• Stay abreast of government regulations and applicable standards with revised or emerging changes and trends to quality regulations and industry methodologies across the globe through continuous professional development and education (publications, seminars, peer/industry networking).
• Participate with quality and management teams to drive continual improvement by harnessing lessons learned, maintain effective and open communication, and share standard methodologies to foster cross-functional partnerships with colleagues and business partners.
• Develop and deliver auditor training materials for internal quality auditors across the network
• Perform other duties as assigned.

How Will You Get Here?

Education

• Bachelor of Science (B.Sc.) in Chemistry, Biology, Pharmacy, or other related fields.  STEM and/or advanced degree in related field preferred.

Experience:

• Minimum 10 years of quality management systems work experience within a regulated industry.
• Minimum 6 years of practical auditing experience within certified quality management systems with performing audits for ISO 13485 and medical devices regulatory QMS programs.

• 4+ years of full-time, hands-on (R&D, manufacturing, and/or testing) work experience in the field of medical devices and/or related sectors.
• Two years in the area of quality management (experience working in an organization governed by regulations and standards).
• Experience in quality management-related activities and medical devices in the area of product design, product development, and/or manufacturing of medical or in vitro diagnostic medical devices.

Knowledge, Skills, Abilities:

• Expert level knowledge of quality management system standards such as FDA GxP, 21 CFR Part 820, 803, 806, 210, 211 QSR, ISO 13485, ISO 9001 and applicable global regulatory requirements (e.g. FDA, EU, MHRA, MDSAP, etc.) within the areas of medical devices and/or pharmaceuticals required.
• Knowledge of processes used in the relevant industry’s testing and manufacturing (e.g. sterilization, biocompatibility, stability, process validation, risk assessment, etc.).
• Familiarity with ERP and quality management system software (e.g. TrackWise, Master Control, SAP).
• Software auditing experience preferred.
• Experience with methods and techniques related to quality and regulatory, including auditing principles and techniques, quality terminology, quality administration principles, and statistics.
• Effective listener, sound judgment, excellent collaboration and problem-solving skills within a team environment.
• Ability to interface with technical resources and scientifically based teams.
• Strong oral and written communication, presentation, and technical writing skills (English).
• Ability to work both independently and within a team and employ effective time management and critical thinking skills.
• Capable to conduct remote auditing, when required.
• Organized and detail oriented and able to prioritize multiple tasks.
• Lead Auditor certification preferred.

Physical Requirements:

• Position may require frequent communication and walking to other areas in which designated PPE will be required.
• Sitting, standing, and/or walking for extensive periods of time.
• Close visual acuity and color vision to perform an activity such as preparing & analyzing data, viewing a computer monitor, reading, report writing, visual inspection, and use of measurement devices.
• Employee may occasionally lift and/or move up to 10 pounds.
• Ability to travel within the Continental US and Internationally.  Typically 30-40% but could range from 30-60% travel requirements based on business needs.

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us . As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

EEO/Reasonable Accommodation:

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.

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