ABEC · 1 day ago
Global Quality Manager (Disposable/Single Use Containers)
Bethlehem, PA
Full-time
Onsite
Senior Level
5+ years expABEC is a leading supplier to the biopharmaceutical manufacturing industry, and they are seeking a Global Quality Manager to lead their Disposable/Single Use Quality team. This role involves overseeing quality staff, ensuring compliance with standard operating procedures, and driving quality improvement initiatives within the organization.
BiotechnologyInformation TechnologyManufacturing
Responsibilities
Oversee all DC Quality staff
Coach, develop and provide guidance to DC Quality members (Team Leads, Specialists, DC TOP coordinators and Technicians)
Ensure cross-training of all DC Quality staff, so that all internal and external (service/installation/training) needs can be met
Drive efficiency and productivity improvements within the team
Review and evaluate site DC Quality staff performance
Maintain and ensure compliance to ABEC Standard Operating Procedures (SOPs)
Support and maintain ABEC quality procedures, practices and guidelines, including best industry practices such as Good Documentation Practices (GDP)
Participate in process, internal and mock customer audits, as directed
Perform vendor qualification or re-qualification audits, as directed
Coordinate and support Customer audits of the ABEC site, as directed
Coordinate assigned CAPA activities (Root cause analysis, short- & long-term corrective and preventive actions) Coordinate assigned Continuous Improvement initiatives, driving both cost and process improvements
Coordinate Quality System Change Management assignments as directed
Coordinate calibration activities at all ABEC DC facilities
Coordinate qualifications of external gamma and x-ray irradiator sites
Coordinate quarterly qualifications of DC manufactured products through the analysis of test articles
Review and qualify new manufacturing equipment and ensure proper IQ/OQ/PQ protocols are followed
Report to the Global Director of DC Operations on the status and metrics of the quality program for required sites
MRB Process signer, and trend analysis
Maintain documents in ABEC archives
Support and maintain ABEC Key Initiatives and Core Values
Execute other tasks as assigned
Ability to travel domestically and internationally as required
Qualification
Required
Bachelor's Degree in an Engineering discipline or related Life Sciences field
Minimum 5 years post graduate work in a Quality or Validation field, including leadership experience in a manufacturing environment
Experience with cGMP, ISO 9000 or equivalent
Preferred
Experience with reporting of KPI metrics of the quality program for specific site such as DPM a plus/preferred
ASQ CQE, ASQ, CQM and Six Sigma a plus/preferred
Benefits
Paid holidays and vacation time
Medical, dental and vision insurance (benefits start day 1)
Company paid life insurance
Generous 401K plan (40% match)
College tuition benefit program
Employee Referral Program
Company
ABEC
ABEC has been a global leader in delivering integrated process solutions and services for manufacturing in the biopharmaceutical industry.
501-1000 employees
H1B Sponsorship
ABEC has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2016-09-15Seed
Leadership Team
S
Scott Pickering
CEO & Chairperson
Jack Wilson
Founder and Chairman of the Board
Recent News
Private Equity Wire
2025-06-11
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