GXP Quality Manager

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What this job involves - The GXP Quality Manager is responsible for oversite and establishing quality processes and policies to ensure that the company is providing quality control and reviewed for client deliverables. Also, responsible for implementing processes throughout the Portfolio while preparing for monthly and quarterly audits. The GXP Quality Manager will be responsible for managing the organizations compliance, training support, vendor performance, collaboration with senior management, and other tasks as assigned.

What is the day to day?

• Increase the effectiveness and efficiency of Support Services through improvements to each function (People & Culture, Quality and Safety) as well as coordination and communication between functions.
• Drive initiatives in the management team and organizationally that contribute to long-term operational excellence.
• Responsible for the oversite/trending of Deviations ( Non-Conformance) in the client Deviation system
• Initiate and own Minor Deviations in the Deviation system.
• Advise team members and provide support for non-conformances including investigations and action planning.
• Improve the operational systems, processes, and policies in support of organizations mission -- specifically, support better management reporting, information flow and management, business process and organizational planning.
• Manage and increase the effectiveness and efficiency of Support Services (People & Culture, Quality and Safety), through improvements to each function as well as coordination and communication between support and business functions.
• Play a significant role in long-term planning, including an initiative geared toward operational excellence.
• Oversee overall quality management, planning, systems, and controls.
• Primary client interface around quality issues
• Develop company Quality policies and procedures; gain sign-off on these from senior management; train employees in implementing all QA standards; ensure all employees are following guidelines for QA
• Oversee and maintain the JLL quality manual and quality management system
• Oversee quality business process procedure development
• Work with outside third-party consultants as needed for implementing company quality procedures.
• Serve as primary liaison on Life Science Counsel in addressing regulatory issues, quality coordination, and company quality requirements for delivery
• Support, own quality standards as assigned
• Prepare and support the ISO-9001:2015 audit
• Read and understand applicable Service Level Agreements and help achieve Key Performance Indicators as they relate to quality and compliance.
• Management of the GxP third-party vendors' compliance program (e.g., qualification, agreements, audits, performances, etc.)
• Serve as the account quality subject matter expert and ensure implementation of and compliance with the client and JLL quality management systems, policies, and procedures.
• Collaborate with account wide team and proactively share and reapply all learnings, successes, and best practices.
• Maintaining a safe and complaint culture by identifying preventative measures.

Desired experience and technical skills -

Required

• At least 5 years' experience in Quality or Operations Management required
• BS Degree (Engineering or Quality Discipline Desired)
• Concurrent with 7 years industry experience either in the corporate environment, third party service provider or as a consultant
• Combination of 5 years in Pharmaceutical / Biotech / GMP's / QA / QC / Compliance environments
• Demonstrated leadership and vision in managing staff groups and major projects or initiatives.
• A demonstrated commitment to high professional ethical standards and a diverse workplace
• Excels at operating in a fast pace, community environment
• Excellent people manager, open to direction and collaborative work style and commitment to get the job done
• Ability to challenge and debate issues of importance to the organization
• Ability to look at situations from several points of view
• Persuasive with details and facts
• Delegate responsibilities effectively
• Experience leading/managing a large, complex and geographically dispersed team.
• Technically proficient in operations of Quality Management Systems and Asset Management Systems

Work Environment

• Based inside of bio-pharmaceutical manufacturing areas
• Monday to Friday, overtime as needed, and periodic travel (up to 10%)
• Performing audits around campus with the ability to bend, knee, walk and stand for extended periods of time
• Serves as a representative of the company and is expected to act on the company's behalf with complete integrity and with the company's and customers' best interests in mind at all times

Estimated total compensation for this position:

The total compensation range is an estimate and not guaranteed. An employment offer is based on an applicant's education, experience, skills, abilities, geographic location, internal equity and alignment with market data .

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If this job description resonates with you, we encourage you to apply, even if you don't meet all the requirements. We're interested in getting to know you and what you bring to the table!

Personalized benefits that support personal well-being and growth:

JLL recognizes the impact that the workplace can have on your wellness, so we offer a supportive culture and comprehensive benefits package that prioritizes mental, physical and emotional health. Some of these benefits may include:

• 401(k) plan with matching company contributions

• Comprehensive Medical, Dental & Vision Care

• Paid parental leave at 100% of salary

• Paid Time Off and Company Holidays

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