Manager, Quality Assurance
2 weeks ago
Who We Are: Harvesting Hope with a Growing Family
At Merz Therapeutics, we take a nurturing approach to our organization - treating colleagues like family, embracing our whole selves and creating a company culture that encourages growth and decisive action. We are committed to caring for whole communities by focusing on individuals suffering from movement disorders and neurological conditions and the healthcare providers dedicated to helping them, while simultaneously bolstering our team members in a united effort to make a difference.
Step into the future with us at Merz Therapeutics, where our family roots meet a bold new vision. Together, we're embarking on a transformative journey, blending time-honored traditions with exciting new products.
The Manager, Quality Assurance will provide assistance with all quality system functions with a focus on technical product quality complaint management. This will include complaint intake, data processing, case tracking, complaint returns, quality investigations, case closeout and customer responses.
- Responsible for development and oversight of the Product Quality Complaint Program in the US and Canada
- Liaison to global Quality functions
- Compliance of quality complaint operations with Quality related requirements set by authorities and Merz-internal
Technical Product Quality Complaints
- Complaint intake, data processing, case tracking
- Complaint returns and product replacements/credits
- Conducting Technical Complaint Investigations
- Case closeout and customer responses
- Complaints trending activities, monitoring metrics
- Further developing the complaints program for US and Canada.
- Contributing to the development and operations of the Quality Management System requirements for Merz therapeutics U.S. within Global therapeutics Quality Management System
- Working with regulatory officials during local quality inspections and supporting all Merz sites globally with any requests for information from an authority inspection
- Local Complaints system/program SME for internal corporate audits and authority inspections
- Driving quality improvement activities
- Supporting Merz therapeutics U.S. and Canadian recall activities (process, communication, reporting)
- Responsible for contributing to local Quality Management Reviews
- Overseeing a team of quality engineers
- Training new hires and ensuring team is trained to perform job functions
- Developing employees
- Maintaining team engagement
- Embodying Merz values and leadership qualities
- Team management administrative responsibilities (approving time-off, performance appraisals, etc.)
- Authoring and implementing Quality Assurance policies and procedures
- Staying up to date on training requirements
- Contribute to the Quality System process related to Corrective/Preventive actions and nonconformance control, including capturing data associated with product deviations, nonconformances, CAPAs and complaints and analyzing the data for the reasons of Quality Improvement and reporting
- Responsible for maintaining compliance with Global therapeutics Quality Management System
- Participating in internal auditing system by global quality assurance
- Liaison to Global Quality functions, ensuring local compliance to global requirements and ensuring consideration for local requirements within global system
- Participate in cross-functional project teams, when appropriate
- Managing collaborative relationship with Global therapeutics R&D, Global Technical Operations and Global Aesthetics Quality Management team
- Assist with adherence to all Federal, State and Local Regulations controlling the manufacture of medical device and drugs
- Bachelor's degree in a Physical Science or Engineering, or equivalent experience is Required
- Minimum of 8+ years of experience in the pharmaceutical or biotechnology industry with at least 5 of those years in QA or closely related field is Required
- Experience working in and with different people and organizational cultures, supporting people with diverse backgrounds, attitudes and cultural differences is Preferred
- Minimum 3 years people management experience is Required
- Don't meet every single requirement? Studies have shown that women and people of color are less likely to apply to jobs unless they meet every single qualification. At Merz Therapeutics we are dedicated to building a diverse, inclusive, and authentic workplace, so if you're excited about this role but your past experience doesn't align perfectly with every qualification in the job description, we encourage you to apply anyways. You may be just the right candidate for this or other roles.
Recruitment Note: Merz Therapeutics only sends emails from verified "merz.com" addresses and never asks for sensitive, personal information or money. If you have any doubts about the authenticity of any type of communication from, or on behalf of Merz Therapeutics, please contact Therapeutics.HR@merz.com
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