Global Quality Manager (Cleanroom)

Company Background:

For over 50 years, ABEC has been a leading supplier to the biopharmaceutical manufacturing industry. ABEC's unique value is based on combining long experience with the ability to engineer, design, manufacture, commission, qualify, and service the entire bioprocess to reduce overall cost, shorten time to market, and maximize productivity. ABEC's products include process and equipment engineering/consulting services, comprehensive site services, and stainless steel and single use bioprocess equipment, including bioreactors and fermenters, filtration and chromatography systems, prep and hold systems, and cleaning/sterilization systems.

Benefits include:

Healthcare reimbursement program

Company pension plan

College tuition benefit program

Employee Referral Program

Position Summary:

The Global Quality Manager leads the Global Disposable/Single Use (DC) Quality team with implementation of company-wide operations procedures and process to support the overall Quality Assurance plan. This role supports Quality improvement throughout the cleanroom and within the team concept. This role will participate as a cross-functional team member within the assigned goal-oriented team.

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

Qualifications:

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.

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