ESSENTIAL JOB FUNCTIONS: Manages the LLC Quality Systems to achieve and maintain compliance with cGMP, ISO9001,, ISO 13485, and 21 CFR part 11, and part 820 (Quality System Regulation). Trains teammates on cGMP in regard to the warehousing and distribution of pharmaceuticals and medical devices in order to meet FDA, DEA, and other regulatory requirements. Provides validation expertise and authoring of process and system validations to include building mapping and other processes as identified. Provides support and oversight for local security systems and environmental monitoring.
Serves as Deputy Management Representative in conducting periodic Management Reviews of the suitability and effectiveness of the Quality System as it pertains to the LLC. Develops, implements, and monitors Quality System policies and procedures to assure products distributed and stored comply with client and Regulatory requirements. Interfaces with clients and their QA organizations to review policies and procedures, regulations, and work instructions. Facilitates internal and external audits of negotiated processes and procedures.
Oversees the 3PL business units audit program providing guidance on improvement plans. Leads teammates and resources involved in legal regulatory compliance issues, including research, regulation interpretation, and interaction with outside parties. May negotiate regulatory issues with Federal and state agencies as directed by the Director, Regulatory. Participates in FDA and other regulatory body audit/meeting preparations.
May act as regulatory representative at FDA meetings, responses to agency inspections and audits and conducts follow-up activities; participates as a liaison with external Quality System auditors and Regulatory bodies. Assists in the filing of reports required by DEA e.g. Form 106, 222, ARCOS. Ensures all regulatory requirements are met regarding scheduled drugs, dating merchandise, storage requirements and reporting agencies that include DEA, FDA, and others.
Works with 3PL Management to ensure that LLC client project implementations were in compliance with regulatory requirements. Through LLC KPI metric reviews, monitors and reports progress of 3PL business against agreed upon compliance goals and objectives. Implements and measures the success of compliance strategies and approaches for 3PL services and technology. Provides direction on standard processes and work instructions for warehouse management, inventory management, client specific and transportation management to support regulatory or operational compliance requirements as it relates to the LLC.
Requiring ongoing review, audits, revision implementation and verification. Oversees the Quality Inspection process in VAS to establish criterion according to FDA requirements and client expectations and assure standards are maintained and executed. Through Service Action Requests, determines, evaluates and monitors progress of elimination of non-conformities in service, process and/or product according to corrective action preventive action (CAPA) procedures. Monitors and oversees all CAPAs which relate to the LLC, assuring that they comply with OM HCL procedures.
Participates in the Internal Audit process and vendor management as it relates to supplier audits for LLC and RLC. Participates as requested with Corporate (Richmond) and Redlands for GMP, QSR or DEA matters. Job Requirements SUPPLEMENTAL JOB FUNCTIONS: Performs additional duties as directed. EQUIPMENT, TOOLS AND WORK AIDS: General office equipment to include PC.
WORKING CONDITIONS AND ENVIRONMENTAL HAZARDS: Inside working conditions. No environmental hazards indicated for this classification . Travel is required (approximately 10%). STRENGTH REQUIREMENT: Sedentary Work: Exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body.
Sedentary work involves sitting most of the time, but may involve walking or standing for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met. TYPE OF PHYSICAL REQUIREMENTS: Acuity, near Clarity of vision at 20 inches or less. Handling Seizing, holding, grasping, turning, or otherwise working with hands.
Fingers are involved only to the extent that they are an extension of the hand. Fingering Picking, pinching, or otherwise working with fingers primarily (rather than with whole hand or arm as in handling). Talking Expressing or exchanging ideas by means of the spoken word. Talking is important for those activities in which workers must impart oral information to clients or to the public, and in those activities in which they must convey detailed or important spoken instructions to other workers accurately, loudly, or quickly.
Hearing Perceiving the nature of sounds. Hearing is important for those activities which require ability to receive detailed information through oral communication, and to make fine discriminations in sound, such as when making fine adjustments on running engines. QUALIFICATIONS: A. EDUCATION & FORMAL TRAINING: Undergraduate Degree in Science or related technical field; Professional Development managing compliance in a cGMP regulated environment.
B. WORK EXPERIENCE: At least 5 years of experience in auditing and/or compliance related to supply chain management in the healthcare industry required; third party logistics and/or international logistics management experience preferred. C. KNOWLEDGE, SKILLS, & ABILITIES: Demonstrated skill in the design, development, and interpretation of regulatory action plans Working knowledge of aspects of distribution, regulatory, and legislative environments Ability to independently identify compliance risks, make decisions independently and escalate when necessary
Owens & Minor - 9 months ago
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