QA Supervisor - Complaint Management
QA Supervisor - Complaint Management
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1 Vacancy
Job Description
Work Schedule
Standard (MonFri)Environmental Conditions
OfficeJob Description
Discover Impactful work:
As a QA Supervisor Complaint Management for Product Complaints you will be responsible for the management of a team performing product complaint investigations received from clients. By working with subject matter experts (SMEs) in the operations areas you will focus on the compliance of these systems to ensure inspection readiness and to facilitate improvement in the investigation program. Additionally as Thermo Fisher Scientific is focused on the customer experience you will be communicating the status of these items with customers to ensure that their expectations are being met.
Key Responsibilities:
Collaborate with Subject Matter experts (SME) providing independent and objective quality advice supporting business procedures managed by SMEs.
Provides Quality oversight related to continuous improvements (CI) associated with our QMS through metrics and key performance indicators.
Present investigation findings in review boards (Deviation or CAPA) as well as to the impacted customers
Supports the Business Process Owner network by ensuring riskbased improvements to procedures to ensure that they are simple efficient and fit for purpose while maintaining regulatory compliance.
Lead a team ofpersonnel ensuring teams organizational performance and succession planning
Direct and prioritize the investigations team to ensure regulatory requirements client commitments and business needs are met
Foster a culture of strong employee engagement collaboration flexibility and competitiveness by improving competence industry understanding and executional skills
Administer and oversee Thermo Fisher Scientifics investigation and CAPA computerized systems access etc.
Mentor and train the staff members on investigation process
Provide investigation guidance and expertise for complex deviations to all teams on site
Supports a robust regulatory intelligence system by monitoring changing regulations and ensuring that the BPO network incorporates changes efficiently and timely.
Core Qualities and Competencies:
Excellent leadership skills to motivate team to adapt to new ways of working
Strive to improve the performance of the team by proactively identifying system improvement opportunities
Use critical thinking and engage in problem solving
Be able to perform statistical analysis when there is a large body of data
Understand and employ risk analysis skills
Strong communication skills to effectively interact with internal teams regulatory authorities and clients
Ability to resolve conflict within the team and in a cross functional setting
Excellent organizational skills with proven track record to prioritize when timeline conflicts exist
Educational and Experience Requirements:
Bachelors Degree within a Science and/or Engineering field
A minimum of 5 years in a cGMP quality/manufacturing role in a pharmaceutical food or cosmetic environment
Experience in management of a team in a regulatory environment
Experience in cGMP principles pertaining to investigations and CAPA
Expertise in technical writing skills
Expertise in practical problem solving and continuous improvement projects
Experience in direct communication with clients and regulatory authorities
Proficient in Microsoft Suite (Word Excel PowerPoint)
Knowledge of adult learning methodologies; ability to coach and train others
Physical Demands:
While performing the duties of this job the employee is required to walk sit and use hands handle or feel tools or controls reach with hands and arms balance stoop crouch bend talk and hear. Typically located in a comfortable indoor area.
Required Experience:
Manager
Employment Type
Full-Time
