Sr Manager, QA

Work Schedule

Environmental Conditions

Job Description

Job Title: Sr. Manager, Quality Assurance – Product Quality Lead (PQL)

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

St. Louis MO / Pharma Services Group

How will you make an impact?

The QA Sr. Manager – PQL is an expert in quality assurance professional that provides leadership and experience within the Quality Assurance function.  The QA Sr. Manager will lead a team of professional Quality Assurance personnel to support internal and external customers in matters of product quality and compliance. The QA Sr. Manager is expected to take the initiative to improve the quality of operations, maintain a quality culture, and cultivate a culture of continuous improvement and superior customer service. 

What will you do? (Responsibilities)

• Coordinates, manages, and ensures the successful day-to-day operations of the Quality Assurance – Product Quality Leads Team (QA-PQL).
• Communicating priorities and distributing work assignments to direct reports.  Ensure all work performed by staff is performed in a safe, timely, and compliant manner.
• Ensures the QA – PQL team successfully perform batch disposition activities to meet specified timelines.
• Ensures the batch disposition process is robust and continually seek ways to improve the disposition process relative to process efficiency, timeliness, and compliance to process metrics.
• Collaborating with customers to ensure clear and open communication is maintained when customer concern of issues are required by QA staff.
• Providing effective feedback and coaching of direct reports in technical skill development, job performance, career development opportunities and taking disciplinary actions if vital.
• Ensures quality and compliance are maintained in the face of customer challenges to internal decision making, and to be able to effectively communicate and work with customers to resolve any disagreements that arise during the process.
• Establish meaningful goals and metrics for the team and lead performance to the goals and metrics.
• Provides leadership to assigned staff by performing the following: 
  • developing and empowering staff
  • cultivating relationships
  • putting staff in a position to succeed
  • meeting their personal career goals while also achieving organizatonal goals
  • building effective teams that apply their diverse skills and perspectives to achieve common goals
  • driving engagement and crafting a climate where staff are motivated to do their best.
  • cultivate a culture of continuous improvement and superior customer service 

• Bachelor’s Degree in Life Sciences (chemistry, biology, biochemistry), Chemical / Biochemical engineering, or other scientific field

• 5+ years of confirmed experience in Quality / Manufacturing / Engineering in a regulated environment
• 3+ years of confirmed Supervisory experience
• Client interfacing experience a plus

Knowledge, Skills, Abilities

• Strong knowledge of FDA/EMA regulatory requirements applicable to pharmaceutical or biologics Quality Systems.
• Ability to apply GMP regulations and other international guidelines to all aspects of the position.
• Technical knowledge of biopharmaceutical manufacturing is desirable.
• Strong interpersonal and communication skills and a demonstrated ability to make key decisions.
• Proven strong attention to detail, problem solving, and critical thinking skills
• Critical thinking with the ability to prioritize multiple priorities simultaneously.
• Continuous improvement mentality
• Able to work collaboratively with various departments in the organization and clients to identify and implement solutions to address quality/compliance issues.

Benefits:

We offer driven 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.

Apply today! http://jobs.thermofisher.com

Disclaimer: 

This job description presents the general content and requirements for the performance of this job.  The description is not to be construed as an extensive statement of work, responsibilities, or requirements.  Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to describe an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  Any language contained herein is intended to fully abide by all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

Thermo Fisher Scientific is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We strive to build an inclusionary work environment and prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

Accessibility/Disability Access

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