QualityCompliance Manager

JLL empowers you to shape a brighter way.

Our people at JLL are shaping the future of real estate for a better world by combining world class services advisory and technology for our clients. We are committed to hiring the best most talented peopleand empowering them tothrive grow meaningful careers and to find a place where they belong. Whether youve got deep experience in commercial real estate skilled trades or technology or youre looking to apply your relevant experience to a new industry join our team as we help shape a brighter way forward.

Quality Manager

The Quality/Compliance Manager must have a strong background in quality assurance requirements for a Biotech/Pharmaceutical Manufacturing facility from an operations facilities and maintenance perspective. This position is responsible for ensuring that the work conducted by the Facilities team and its subcontractors perform the work in full accordance with contractual procedural and regulatory requirements within a cGMP culture environment. This Manager must have a solid understanding of cGMPs as they relate to the performance of maintenance and repairs of equipment facilities and utilities. An Engineering background or equivalent experience in lieu of would be desired. The position requires the ability to prepare and manage documents investigations CAPAs audits change control documentation and training materials for use by the facilities team in the performance of their work.

In addition this position is expected to interface with the sites quality unit to ensure that through the established Quality Agreement all applicable regulations and procedures are followed and that the work performed by the team is documented and recorded in the proper fashion. It is responsible for sustaining a Quality program and culture at a state-of-the-art cGMP manufacturing facility. This person must have experience working at an FDA regulated manufacturing facility in a quality assurance or quality control capacity. A background and understanding of FDA regulations including 210 CFR part 210 and 211 would be desired but not required.

The Quality/Compliance Manager must have a strong commitment to quality assurance and a willingness to help develop a quality first culture on the Site. Must be self-motivated detail oriented comfortable working in a dynamic team environment with minimal supervision. The person must have good oral and written communication skills including the ability communicate and gain the trust of all levels of management and interface with a diverse customer base including technical and non-technical personnel.

Responsibilities

• • Perform investigations of significant event deviations along with the corresponding root cause analysis (RCA) impact assessment and trend evaluations.
  • Lead assigned Corrective and Preventive Actions (CAPA)
  • Developments and reviews of trend analysis reports related to the facility scope of work.
  • Management of the GxP Contractors compliance program (e.g. qualification agreements audits performances etc.).
  • Oversee the quality/compliance program as it relates to facility support systems including maintenance of equipment environmental monitoring systems HVAC utilities and site support services such as calibration janitorial cleaning pest control garments and shipping/receiving activities.
  • Manage the sites self-assessment program along with the corrective actions as a result of.
  • Maintain all infrastructure and compliance documentation for the facility for the purpose of maintaining regulatory compliance with Contractual Procedural Federal State or Local law requirements.
  • Reads and understands the applicable Service Level Agreements standard operating procedures helps achieve the Key Performance Indicators and scores favorably on the client satisfaction surveys.
  • Support and oversee the teams training compliance program along with the review of corresponding training curricula.
  • Ensures appropriate follow up with customers.
  • Seeks to continuously improve quality processes systems and overall client satisfaction.
  • Provides direction/information to vendors facilities staff and service providers as required to ensure that quality assurance expectations are communicated and followed.
  • Performs additional job duties as requests analysis and reporting.
  • Ensure adherence to ISO 9001:2015 standard requirements.

JOB REQUIREMENTS

• • BA/BS in Science is preferred or equivalent quality engineering and production/facility operations experience.
  • Have a minimum of three to five (5) years of experience in Pharma Biotech or similar life science sector that are governed in GMP regulations systems and processes working in a Quality Assurance role.
  • Knowledge of Quality Engineering techniques such as Investigations RCAs CAPAs Audit programs Vendor Qualification and Quality Management Systems
  • EIT or PE a plus
  • Strong working knowledge of computer applications including MSOffice
  • Working knowledge of Quality System such as TrackWise Success Factors Infinity etc.
  • Demonstrated verbal/written communication skills
  • Proven record of excellent internal and external customer service

This position does not provide visa sponsorship. Candidates must be authorized to work in the United States without sponsorship.

Location:

If this job description resonates with you we encourage you to apply even if you dont meet all the requirements. Were 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

• Early access to earned wages through Daily Pay

At JLL we harness the power of artificial intelligence (AI) to efficiently accelerate meaningful connections between candidates and opportunities. Using AI capabilities we analyze your application for relevant skills experiences and qualifications to generate valuable insights about how your unique profile aligns with the specific requirements of the role yourepursuing.

JLL Privacy Notice

Jones Lang LaSalle (JLL) together with its subsidiaries and affiliates is a leading global provider of real estate and investment management services. We take our responsibility to protect the personal information provided to us seriously. Generally the personal information we collect from you are for the purposes of processing in connection with JLLs recruitment process. We endeavour to keep your personal information secure with appropriate level of security and keep for as long as we need it for legitimate business or legal reasons. We will then delete it safely and securely.

For more information about how JLL processes your personal data please view our Candidate Privacy Statement.

For additional details please see our career site pages for each country.

For candidates in the United States please see a full copy of our Equal Employment Opportunity policy here.

Jones Lang LaSalle (JLL) is an Equal Opportunity Employer and is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process including the online application and/or overall selection process you may email us at . This email is only to request an accommodation. Please direct any other general recruiting inquiries to our Contact Us page > I want to work for JLL.

Accepting applications on an ongoing basis until candidate identified.