Manager, Regulatory & Quality Compliance in Louisville, KY at Owens & Minor, Inc.

Date Posted: 7/27/2018

Job Snapshot

Job Description

This position has accountability for Regulatory, Quality and Compliance issues, including state, federal, and local regulatory issues, risk management issues, training and development, product compliance, special handling regulations, and related information technology requirements.  Accomplishes goals through matrix management and oversight of resources and teammates. Reports to the Director, Regulatory Compliance. 



ESSENTIAL JOB FUNCTIONS:

  1. 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).  

  1. 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.

  1. 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.

  1. 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.

  1. Develops, implements, and monitors Quality System policies and procedures to assure products distributed and stored comply with client and Regulatory requirements.

  1. 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 unit's audit program providing guidance on improvement plans.

  1. 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.

  1. 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.

  1. Assists in the filing of reports required by DEA - e.g. Form 106, 222, ARCOS.

  1. Ensures all regulatory requirements are met regarding scheduled drugs, dating merchandise, storage requirements and reporting agencies that include DEA, FDA, and others.

  1. Works with Management to ensure that LLC client project implementations were in compliance with regulatory requirements.

  1. Through LLC KPI metric reviews, monitors and reports progress of business against agreed upon compliance goals and objectives. Implements and measures the success of compliance strategies and approaches for services and technology.

  1. 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.

  1. Oversees the Quality Inspection process in VAS to establish criterion according to FDA requirements and client expectations and assure standards are maintained and executed.

  1. 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. 

  1. Monitors and oversees all CAPAs which relate to the LLC, assuring that they comply with OM HCL procedures.

  1. Participates in the Internal Audit process and vendor management as it relates to supplier audits for LLC and RLC.

  1. Participates as requested with Corporate (Richmond) and Redlands for GMP, QSR or DEA matters.

SUPPLEMENTAL JOB FUNCTIONS:

          Performs additional duties as directed

QUALIFICATIONS:

 

          EDUCATION & FORMAL TRAINING:

Four-year undergraduate degree required.

          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.

          KNOWLEDGE, SKILLS, & ABILITIES:

 

A.   Demonstrated skill in the design, development, and interpretation of regulatory action plans

B.   Working knowledge of aspects of distribution, regulatory, and legislative environments

C.   Ability to independently identify compliance risks, make decisions independently and escalate when necessary

D.   cGMP regulatory compliance required

E.   Knowledge of FDA regulations required

F.    Proven ability to liaise with Regulatory Agencies having served as lead in Agency Interactions

G.   Knowledge of DEA regulations

H.   Excellent verbal communication, presentation, and facilitation skills

I.     Very strong negotiation, influencing and problem solving skills

J.    Computer Skills - proficient with Microsoft Office, other Quality Software tools desired, and WMS programs such as RedPrairie

K.   Ability to lead and coach others and to work as part of a team

L.    Customer first focus

M.  Significant experience in supply chain strategies, operations and project management

N.   Experience in hardware/software medical device development, regulations, standards, and current industry practices



EQUIPMENT, TOOLS AND WORK AIDS:

          General office equipment to include PC.      

WORKING CONDITIONS AND ENVIRONMENTAL HAZARDS:

  1. Inside working conditions.

  1. No environmental hazards indicated for this classification.

  1. 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. 

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