Compliance Program Senior Manager

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Job description

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them. Our distributed team of more than 90,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visit .

Position Summary:

The Compliance Program Senior Manager will be responsible for crafting, leading and coordinating a compliance management system cross the Laboratory Chemicals Division in North America. In particular, lead all aspects of compliance to US DEA Controlled Substance regulation and US Agency/CFR rules and regulations (EPA, FDA, FAA, ATF, etc..).

This role will identify improvements to the QMS and any other processes which may impact compliance to critical regulations (i.e. Controlled Substances and Precursors).

Key Responsibilities:

• Design and lead all aspects of effective process implementation and monitoring
• Lead and coordinate compliance to Controlled Substance regulations
• Provide Subject Matter Expertise
• Connect with personnel at the ThermoFisher organization.
• Make experienced compliance decisions
• Identify and lead proactive improvements (strategic and tactical)
• Support subject matter audits by external agencies and ThermoFisher Corporate Surveillance teams for sites in Laboratory Chemicals network. Including audit schedules, agendas, preparation, response, and correction.
• Establish, supervise, analyze and interpret Key Performance Indicators to measure compliance program progress and efficiency.
• Provide insights and reporting on potential compliance program risks to Leadership. Identify common issues amongst the Laboratory Chemical sites.
• Maintain and continually improve the Controlled Substance Program Master Data process. Establish periodic contact with Corporate Surveillance to ensure controlled substance site data is complete and accurate.
• Proactively supervise master data for date-sensitive thresholds and work with sites to request renewals as needed to ensure licenses, permits and registrations remain current and result in no interruption to business.
• Stay current on controlled substance / compliance regulations Policies and Procedures as the need arises.

Requirements/Qualifications:

Educational/Career Experience:

• Bachelor's degree in chemistry, engineering, related science, or regulatory affairs.
• Guide understanding of chemical regulations.
• Applied knowledge regulations and related industry quality system compliance requirements and processes.
• US chemical regulations and quality system requirements.
• Project management and leadership.
• At least 7 years of direct chemical, biopharma, or life science validated experience.

Skills & Qualifications

• Consistent record to influence professional staff in order to achieve goals.
• Demonstrated ability to adjust communication style to interface effectively across all levels of an organization.
• Experience with external surveillance and searching for latest information related to QMS and CSP compliance.
• Self-starter with ability to work independently with little supervision, especially remotely.
• Ability to communicate and develop an internal strategic network while working remotely.
• Strong written and verbal communication skills and effective presentation skills.
• Attention to detail.
• Strong interpersonal and multi-tasking skills.
• Excellent analytical and problem-solving abilities.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status. ACCESSIBILITY/DISABILITY ACCESS Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service people requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-*. Please include your contact information and specific details about your required accommodation to support you.

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