Job Title: QA Manager
Requisition ID: 121270BR
 
 
When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.
 
Location/Division Specific Information
This position is located at our Florence, SC site supporting our small molecules API site.
 
How will you make an impact?
The Quality Assurance Manager will lead, manage and act as a direct liaison between clients and the site’s quality unit to ensure adherence to expectation of the client are being met and facilitating projects through the site’s Quality Systems.   Provides leadership and guidance to the Quality client relations team. This team is essential to maintaining the site’s right-to-operate in support of producing and releasing quality bulk drug substance for clinical and commercial clients. This role will interface closely with other cross-functional groups such as Operations, Maintenance, Engineering, R&D, Business Management and Quality.. 
 
What will you do?           
 

• Provide day to day leadership to Quality client relations staff. Create procedures to ensure compliance with current regulations and best practices.
• Participate on cross functional project team to provide open communication to clients on quality related issues and site standards associated with their project.
• Manage multiple clients, developing trust and confidence through their product’s lifecycle.
• Directly responsible for ensuring client notifications and approvals are performed as defined in product’s Quality Agreement.
• Provide quality oversight of client product related topics including but not limited to deviations, change controls, batch record reviews, batch release, and specification management.
• QA Compliance Specialist will lead and / or support thorough investigations of client-related quality issues (CAPA’s, Discrepancies, Audit Observations, etc.) ensuring effective corrective and / or preventive actions occur.
• As applicable, provide quality oversight of client product validation and pharmacovigilance programs.
• As applicable, manage the development of client product related Annual Product reviews.
• Provide regular status updates on client’s quality expectations to local Quality Assurance team.
• Interface with clients by assisting with addressing their questions and concerns as they relate site strategy for controlling product quality through quality systems.
• Participate in cross-functional teams on process control, improvement, and optimization projects; participate in other continuous improvement projects to enhance client satisfaction.
• Participate in audits and inspections performed by clients.
• Participate in inspections by regulatory agencies, as needed.
• Carry out managerial responsibilities in accordance with the organization's policies and applicable laws.
• Responsibilities include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding, developing and disciplining employees; addressing complaints and resolving issues.
• This position will staff, train and manage a group of QA associates and technical managers in order to perform the tasks in accordance with established standard lead times.
• Administer, document and maintain the ThermoFisher Quality Systems conformance to regulatory requirements and company policies where appropriate through effective utilization of ThermoFisher Quality Systems and tools, as well as direct actions.
• Deploying key metrics in the quality assurance processes and develop effective strategies to ensure continuous improvement and effectiveness of the quality system.
• Perform other duties as required.

 
How will you get here?
 

Minimum of a BS in Chemistry, Life Sciences or related field required
 
 

• Minimum of 10 years of pharmaceutical experience in a QA/QC leadership role, preferably with a plant manufacturing focus
• or an equivalent combination of education and experience.
• Proven supervisory or management experience in a quality role and three to five years of batch review experience in support of GMP manufacturing preferred.
• Knowledge of 21 CFR 110, 21 CFR 211, ICH Q7 and other regulatory standards governing the manufacture of bulk drug substance.
• Demonstrated proficiency in interpretations of cGMP regulations, both US and international, SAP, and LIMS.
• Previous project management experience is a plus
• Experience managing external customers is a plus
• Direct manufacturing experience is a plus
• Tech transfer experience is a plus

 
Knowledge, Skills, Abilities
 

• Must exhibit exemplary behaviors in line with ThermoFisher principles and values
• Demonstrated ability to make quality decisions is required.
• Demonstrated history of building teams and interdepartmental relationships
• Critical thinking with the ability to read, analyze, and interpret technical data
• Good planning and organizational skills
• Ability to lead, train, motivate, and work within a team
• Excellent oral and written interpersonal communication skills
• Experience with data collection, data management analytics and KPI reporting
• Understanding of risk management principles and ability to apply these principles in day to day Quality Management activities, quality and compliance issues and business challenges.
• Strong Microsoft Office skills (especially Word and Excel)
• Must be able to read, write, and communicate in English

 
Physical Requirements:
 

• While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; sit and to talk, hear or smell. The employee is occasionally required to walk and stoop, or kneel, crouch.
• The employee must also occasionally lift and/or move up to 50 pounds.
• Specific vision abilities required by this job include close vision, depth perception, and ability to adjust focus.

 
At Thermo Fisher Scientific, each one of our 75,000 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.com
 
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.