Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 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 complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled 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 www.thermofisher.com. Location/Division Specific Information
Greenville, NC / Pharma Services GroupHow you will make an impact
Supervises and/or leads lower level staff providing direct quality support (e.g. compliance, regulatory assessment, and validation) to the business unit. Performs quality functions to ensure accurate and timely completion with frequent decision making, coordination and communications required. Creates, reviews, approves, tracks and presents documents and procedures required for compliance with pharmaceutical regulations. Identifies areas of non-compliance, review recommendations of others and implement solutions to resolve major quality and productivity issues. Implements systems to ensure compliance with new and changed regulations. Performs activities across key quality functions to support the business units. Prepares and conducts quality systems training across the company.What you will do
1. Prepares, reviews and approves production, validation, audit reports and/or master batch record documents, procedures, and rationales.
2. Manages, leads, schedules, executes and tracks multiple projects of high complexity with multi-disciplinary departments to ensure timely completion of deliverables.
3. Serves as principle/validation liaison for negotiating with clients on agreements/projects and resolution of significant validation, product and regulatory issues. Coordinates, reviews and prepares customer audit responses and reports.
4. Evaluates new regulations, changes to existing regulations and regulatory trends; performs gap analysis to determine efficiencies and take appropriate actions.
5. Establishes actions and implements systems to achieve process improvements and efficiencies to address shortcomings in processes and systems.
6. Serves as principle in hosting and coordinating regulatory inspections performed by the FDA, MCA and other regulatory agencies.
7. Defends policies, procedures, rationales and methods in the area(s) of expertise during regulatory and client audits.
8. Establishes and supervises quality programs and plans (e.g. validation, QAT, supplier certification).
9. Identifies training needs and develop training programs.
10. Works in a safe and responsible manner in order to create an injury-free and incident-free workplace.
Complies with all job-related safety and other training requirements.
11. Performs other duties as assigned.How you will get here
- Bachelor's degree in a related field is required.
Knowledge, Skills, and Abilities
- Four years in the pharmaceutical industry or a regulated industry is preferred.
- Equivalent combinations of education, training, and relevant work experience may be considered.
- Proficient in the use of computerized office applications (e.g. Word, Excel, Outlook) and systems/business applications, project management and demonstrated scientific writing skills.
- Knowledge of cGMPs and FDA/industry expectations.
- Outstanding attention to detail and organizational skills. Self-starter, mature, independent and dependable. Ability to work in a fast-paced environment under pressure, able to multi-task and is results-oriented. Effective time management and prioritization skills.
- Requires discretion and independent judgment. Highly effective verbal and written communication skills.
At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.
Apply today! http://jobs.thermofisher.comThermo 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.