Regulated Services Lead
JLL - East Syracuse, NY
Position Summary:
OVERVIEW
The Site Regulated Services Lead will have a primary focus on managing select site services which require additional oversight due to the regulated environment, including but not exclusive of cleaning/custodial, solid waste & recycling, pest control, lab services and shipping & receiving. The person in the role will strive toward innovation, assist in lowering cost of delivery and work with suppliers to integrate the service into operations while dramatically enhancing the customer experience. The Regulated Services Lead will collaborate with quality assurance to ensure effective participation in and adherence to quality programs. They will drive towards a higher level of cleanliness as well as achieve minimum scoring metrics as stipulated in both Client and Vendor contracts.
The candidate will have a proven career history of successfully managing change and GMP/Quality experience.
This position reports directly to the Site Facility Manager.
ESSENTIAL FUNCTIONS
- Participate in the creation and implementation of inspections and other quality practices and procedures.
- Understand and ensure compliance in GMP space
- Customer Focus: A true innovator and genuine service oriented individual that is able to continuously monitor established quality procedures, and resolve internal quality issues and customer complaints concerning product and or service dissatisfaction.
- Communication: Directly interface, both verbally and written, with client senior management, vendors, and throughout all levels of the organization.
- Compliance: Stay current with all federal and state regulations/codes, comply with specifications, and ensure standards are met.
- Provide support to the site Quality Assurance representative to include training, assigning tasks, performance appraisals, conducting investigations, developing/implementing CAPAs, and monitor procedures to ensure the processes are completed in an efficient and safe manner, and within the scope of company policies and procedures.
- Able to perform/support audits and prepare SOP’s, and training materials.
- Provides direction/information to vendors, facilities staff and service providers as required to ensure that quality assurance expectations are communicated, understood and followed.
- Inspections: Conducts planned inspections of the sites to check the level of service quality provided by in-house and vendor teams. These inspections should serve as an assurance of quality as measured by the surveys received from the clients.
- Provides leadership and direction to advance service quality and enhance the client partnership. Is dedicated to continuously improving operations and influencing the behavior of all employees in the direction of superior and exemplary customer service.
- Supplier Performance Management: Delivers high quality, creative, and cost-effective solutions that delights the client. Monitors work requests watching vendor performance and trends.
- Dramatically raise the bar in vendor quality and service while reducing overall costs.
- Hold vendors accountable for delivering high quality service per contract expectations, partnering with vendors to continuously improve service quality and improvement plans, and resolve/troubleshoot service issues at the site level.
- Analytical Capability: Analyze trends and utilize data to anticipate and proactively address issues in the environment.
- Financial Acumen: Challenges year-over-year increases in costs; pro-actively identifies ways to drive out “process waste” in order to reduce costs.
EDUCATION AND EXPERIENCE
- A bachelor’s degree is desired but not required, directly relevant experience in lieu of degree is acceptable.
- 5 years of relevant quality experience in GxP or ISO9001
- Broad range of business experience acquired through previous work experience.
KNOWLEDGE, SKILLS, AND ABILITIES
- Industry Expertise: Understand the fundamentals of the outsourcing business and a proven leader in the client services arena, including but not limited to, supplier performance management practices. Experience in pharmaceutical manufacturing preferred.
- Must possess strong interpersonal skills with the ability to build rapport quickly
- Knowledge of Quality Engineering techniques, CMMS systems, and Quality Management Systems
- Excellent written and verbal communication skills a must
- Ability to analyze reports for the purpose of ensuring compliance with scope of work
- Excellent PC skills, proficient in all MS applications, in particular Excel, Word, PowerPoint, Visio
GMP PROFICIENCIES
Must have proven, successful GMP or Quality experience in order to manage vendors performing services in GMP space and assist site Service Managers (who will also be required to have GMP or Quality experience)
GMP | PEST CONTROL
- Proven capabilities on addressing and remediating of pest sightings and investigations in a GMP Manufacturing Facility.
- Ability to establish rationales on Pest Control Best Practices.
- Ability to prepare and analyze Pest Control Trend Reports which can be scrutinized by Regulatory Agencies.
- Experience in auditing GMP Pest Control Programs
- Some knowledge in entomology and common insects behavior
- Strong Knowledge of Environmental Controls of GMP Clean Rooms
- Strong understanding of Regulatory Expectations
- Capability to recommend, establish frequency and propose recommended dilutions of cleaning detergents for specific needs and situations.
- Develop cleaning procedures, work instructions and log forms in compliance with regulatory expectations.
- Trainer of Cleaning Methods and Patterns
- Proven capabilities on addressing and remediating investigations related to Environmental Monitoring excursions as it related to a cleaning/disinfection programs.
- Ability to recognize when a GMP Change Control is required when proposing new cleaning methods, detergents and consumables
Start a lasting career with JLL today!
Total Rewards reflects JLL’s investment in employees’ needs and preferences in Career, Recognition, Well-being, Benefits and Pay. We offer a competitive salary and benefits package. To be considered, please visit our Web site at www.us.am.joneslanglasalle.com/UnitedStates/EN-US/Pages/Careers.aspx to apply online. All resumes MUST BE submitted via our web site. Please reference Job 54366BR
#LI
Posted: 30+ days ago
