Sr. Quality & Compliance Manager

JLL empowers you to shape a brighter way.  

Our people at JLL and JLL Technologies 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 people  and empowering them to  thrive, grow meaningful careers and to find a place where they belong.  Whether you’ve got deep experience in commercial real estate, skilled trades or technology, or you’re looking to apply your relevant experience to a new industry, join our team as we help shape a brighter way forward.   

Position Overview:

The Sr. Quality/Compliance Manager, will have a primary function of ensuring that Regional Quality & Compliance Program is properly implemented, maintained, and continuously improved.  The person in the role will strive towards regulatory, procedural, and contractual compliance ensuring Audit Readiness status at all responsible sites. The role will strive towards regulatory, procedural, and contractual compliance ensuring Audit Readiness status.  This Sr. Quality/Compliance Manager will collaborate with site Leads to ensure effective participation in and adherence to quality programs. Together, they will drive towards a higher level of service as well as achieve the minimum scoring metrics as stipulated in both Client and Vendor contracts.

In addition, this position is expected to interface with the client’s quality unit to ensure that, through established Master Quality Agreement, all applicable regulations and procedures are followed, and that the work performed by staff is documented and recorded in the proper fashion. This person must have experience working at an FDA regulated manufacturing facility in a quality assurance or quality control capacity with a solid background understanding of GxP regulations.

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

Responsibilities:

• Develop, implement, support and manage quality programs ensuring that program deliveries  are meet or exceed expectations

• Build successful relationships within account’s personnel and other client personnel to promote confidence, forward planning, and best practices

• Provide management and leadership for the design, development, implementation and sustainability of quality and compliance programs

• Collaborate with site’s team and proactively share and reapply all learnings, successes, and best practices

• Responsible for managing quality programs (i.e. Non-Conformance Investigations, CAPAs, Training Compliance, Vendor Qualifications, Quality Agreements, Audits, Self-Assessments, Document Management, Change Control, Site Quality Culture, etc.) that ensures that the work conducted by the Facilities team, and its subcontractors, perform the work in full accordance with SOP’s, applicable industry regulations, current practices and contractual requirements.

• Perform/support audits and prepare documents, and training materials for use by site staff in the performance of their work.

• Expected to interface with the client’s quality personnel to ensure that all the client’s requirements are followed, and that the work performed by the team is documented and recorded in the proper fashion.

• Manage and report on Quality and Compliance critical & key performance measurements.  Develops and submit status reports related to the Quality Program

• Effectively lead staff by clearly communicating expectations, accountabilities and providing performance feedback for continuous improvement.

• Supervise, mentor, develop and train peer and manage team members.

• Provides management/information to vendors, account staff and service providers as required to ensure that quality assurance expectations and changes to industry regulations are communicated and followed.

• Ensure that JLL’s Life Sciences Quality Management System is properly implemented and consistently met, including ISO 9001:2015 requirements

• Any other duties and tasks as deemed necessary

Qualifications:

• BS degree is required with a minimum of 6 years of experience in quality/compliance programs of pharmaceutical/biotechnology/medical devices facility operations.  Strong related experience in lieu of degree may be acceptable.

• EIT or PE a plus

• Thorough understanding of cGMP’s as they relate to the facilities, utilities, equipment, and laboratories supporting manufacturing activities of pharmaceutical products.

• Understanding of FDA guidance documents and regulations including 21CFR part 11, 210, 211, 600 and 820.

• Strong knowledge of Quality Management Systems such as Investigations/RCA, CAPAs, Audit programs, Vendor Qualification, Document Management and Training

• Ability to prepare and analyze technical reports for the purpose of ensuring compliance with regulations, procedures, and contractual responsibilities

• Ability to recognize and diagnose non-compliance trends and patterns

• Excellent PC skills, proficient in all MSOffice applications, in particular Excel, Word, PowerPoint

• Working knowledge of Quality Management Software such as TrackWise, Success Factors, Infinity, Veeva, etc.

• Capability to work independent, while managing a team

• Excellent oral and written communication skills including the ability communicate to all levels of management and will interface with a diverse customer base including technical and non-technical personnel.

• Proven record of excellent internal and external customer service experience

Location:

On-site –Gurabo, PR

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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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 accomodationrequest@am.jll.com. 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.