The Quality Manager is responsible for Quality Assurance development, implementation and maintenance activities related to the established Quality Management System (QMS) for Boston/Billerica, MA sites.
The Quality Manager is responsible for coordinating staff efforts supporting goals and objectives in accordance with corporate and site goals while maintaining compliance to established standards and applicable regulatory requirements.
(i.e.: ISO9001:2015, ICH Q7, QSR 820) Core Duties and Responsibilities: Partner with DAS Senior Management as well as local Site Management to establish, implement and maintain a compliant QMS necessary to successfully produce and support the research use only products and services (to include, but not be limited to design control, document control, production and process control, nonconformance management, CAPA's, labeling, customer complaints, storage and distribution).
- Ensure a comprehensive and complete QMS is established and implemented to be compliant with applicable regulatory requirements [ISO 9001:2015, ICH Q7 (desired), 21 CFR 820 (desired)] by conducting internal audits, training programs, data review & analysis and all other relevant activities.
- Function as the Management Representative, prepare for and participate in ISO and Customer audits as the primary contact, and manages the Quality Management Review process.
- Carries out supervisory 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 and disciplining employees; addressing complaints and resolving problems.
- Oversees Customer Complaint Handling System, CAPA and SCAR programs, including maintenance of all associated data.Ensures timely analysis and closure of complaints.
- Manage the internal audit schedule and process; maintain all records of internal audits. And respond to and maintain oversight of audit finding remediation.
- Responsible for supplier quality (including audits of suppliers), documentation control and learning management system in accordance with company policies and procedures.
- Offer support and makes recommendations on the implementation of best practices in its area of expertise.
- Leads investigations and resolves potential product quality issues, applying continuous improvement principles for system optimization, as appropriate.
- Develops budget and monitors expenditures.
- Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results
- Support for Learning Management System (LMS) Training - ensure training is properly conducted and documented
- Establish, monitor, and publish appropriate site Quality Metrics
Job Requirements :
- Bachelor's Degree in Science or equivalent
- Minimum of(5) years' experience in quality management
- Good interpersonal skills
- Excellent written and oral communication skills
- Working knowledge of the ISO 9001:2015 and ICH Q7 (desired) Quality management system requirements
- Certified ISO auditor
- Six Sigma expertise an asset
- Experience working in a reagent working environment desired
Knowledge, Skills & Abilities:
- Experience working with Regulatory bodies.
- Experience working in reagent manufacturing environment.
- Background in Six Sigma and Continuous Improvement programs...Black or Green Belt preferred
- Ability to read, analyze, and interpret the most complex documents.
- Superior interpersonal, verbal and written communication skills.
- Excellent organizational, negotiation and problem solving skills
- Ability to make effective presentations on complex topics to senior management.
- Working knowledge of SAP Quality Module, Excel, LMS
- Excellent team building and leadership skills to motivate team members and drive projects to successful conclusion, including when do not have direct authority of resources
- Excellent judgement skills in order to provide strong guidance and counsel to the site and staff
Physical Requirements (if applicable):
PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.
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