Senior Quality Manager

Baxter • Cleveland, OH

1d

About The Position

This is where your work makes a difference. At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond. Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results. Here, you will find more than just a job—you will find purpose and pride.

Requirements

• Thorough knowledge of applicable procedures, specifications, regulations and standards.
• Strong analytical and problem solving skills.
• Ability to manage/supervise a team of employees.
• Good communication and leadership skills.
• Good interpersonal/communication/influencing/negotiation skills.
• Good project management skills.
• Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
• Strong technical written skills
• Applicants must be authorized to work for any employer in the U.S. We cannot sponsor or transfer sponsorship of an employment visa.

Responsibilities

• Manage through subordinates the coordination of the activities both the Chemistry and Microbiology Laboratory.
• Responsible for results in terms of product quality and conformance to regulations and Baxter quality policies.
• Manage the activities of the chemistry laboratory and process validation with responsibility for results in terms of product quality, performance and safety.
• Implements the quality systems procedures and manages compliance in a section or department.
• Understands and assures conformance to regulations in the Chemistry/Microbiology laboratory.
• Manage the activities of the microbiology laboratory with responsibility for results in terms of product quality, performance, and safety.
• Implements the quality systems procedures and manages compliance in a section or department.
• Interfaces with regulators during regulatory inspections.
• May participate in or manage quality assessments of internal operations and suppliers to analyze compliance and assess risk.
• Interacts frequently with subordinate supervisors and functional peer group managers.
• Identifies and manages continuous improvement projects with the objective of achieving quality, reliability, and cost improvements.
• Coordinate and communicate with Lab Services and QA as required to maintain departmental operations.
• Advises on technical procedures, techniques, and equipment, and maintains conformance with specific operational standards.
• Maintains quality checks on the safety of laboratories and insures maintenance of the facilities according to good laboratory practices.
• Reviews testing and laboratory records for accuracy and compliance with cGMP and company policies and procedures.
• Maintains laboratory supplies inventory by checking stock to determine inventory level; anticipating needed supplies; placing and expediting orders for supplies; verifying receipt of supplies and approval of corresponding invoice.
• Oversees daily workflow of the department or direct reports.
• Develop and support career paths and professional growth opportunities for Quality Control staff that will provide continuous improvement in product quality and operations.
• Manage department to ensure timely release of products to meet company and customer quality requirements and timelines
• Following up on non-conformances, investigating corrective actions, and implementing appropriate corrective & preventative actions plans
• Develops budget for the department and ensures adherence to the budget.
• Manages the coaching, training and development process of subordinates.
• Sustain a clean and safe work area using 6S principles
• Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)

Benefits

• medical and dental coverage that start on day one
• insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
• Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount
• 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
• Flexible Spending Accounts
• educational assistance programs
• paid holidays
• paid time off ranging from 20 to 35 days based on length of service
• family and medical leaves of absence
• paid parental leave
• commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• childcare benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed