The Site Regulated Services Lead will have a primary focus on managing select site services which require additional oversight due to a higher exposure in regulated environment, including but not exclusive of the pest control program, cleaning/custodial, lab services and shipping & receiving. The person in the role will strive toward regulatory compliance, 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. 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. The candidate will have a proven career history of successfully managing change and GMP/Quality experience. This position reports directly to the Site Sr. Facility Manager.
Responsibilities:
Compliance:Stay current with all federal and state regulations/codes, comply with specifications, and ensure standards are met. Ensure that produced GxP documents are attributable, legible, contemporaneous, original and accurate (ALCOA). Ensure that contracted service providers are complying with regulatory, procedural and contractual expectations. Adhere and perform all requirements established by the site procedures.
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.
Participate in the creation, revision and implementation of area preventive maintenances, self-inspections and other quality practices and procedures.
Provide support of Quality Assurance to include training, assigning tasks, performance appraisals, risk assessments and monitor procedures to ensure the processes are completed in an efficient and safe manner, and within the scope of company policies and procedures.
Incident Management:Support any incidents/investigation process related to regulated services. This includes, but not limited to, supporting investigations, documenting incidents in corresponding workorders, participating in incident triage meetings and developing/implementation of CAPAs.
Able to perform, support, maintain, reconcile and audit, when required, SOP’s, forms, logs, trackers, site drawings, incident diagrams, presentation graphs and training/awareness materials.
Provides direction/information to vendors, subject matter experts, facilities staff and service providers as required to ensure that quality assurance expectations are communicated, understood and followed.
Analytical capability:Collect Service Data in spreadsheets and perform Trend Analysis. Such analysis must be focused on the anticipation of possible issues and proactively addressing them.
Inspections/Audits: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. Support external and internal audits.
Provides leadership and direction to advance service quality and enhance the client partnership. Ensure on-going continuous improvement 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.
Financial Acumen:Challenges year-over-year increases in costs; pro-actively identifies ways to drive out “process waste” to reduce costs.
Qualifications
Bachelor’s degree in Quality Control, Engineering, Mathematics, Science or another relevant field is desirable but not required, experience in lieu of degree may be acceptable.
A minimum of 5 years of GMP or ISO 9000 experience in manufacturing.
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 have proven, successful GMP or Quality experience in order to manage vendors performing services in GMP spaces subject to regulatory scrutiny and assist site Service Managers.GMP Pest Control Program: 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
GMP/Clean Room Janitorial and Sanitization Programs: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
GMP Shipping/Receiving:Strong capabilities to develop GMP Shipping/Receiving procedures.
Experience auditing shipping/receiving processes
Proven capabilities on addressing and remediating investigations related to shipping/receiving deviations
Experience in the determination, placement and process of environmental data loggers (i.e. TempTales)
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 in both English and Spanish a must
Ability to prepare and 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
