Job Title

Quality Control Manager

Requisition

JR000014846 Quality Control Manager (Open)

Location

Raleigh, NC

Additional Locations

Job Description Summary

SUMMARY OF POSITION:

The Quality Control Manager serves as a Quality Control technical resource to the plant. She/he is the primary point of contact for the testing of all raw materials, in-process, finished goods, and stability samples. She/he manages the Quality Control group and compliance activities to achieve key site and corporate objectives. This individual will provide overall QC leadership regarding cGMP compliance concerns and improvements, as well as manage budget line items, overtime, efficiency improvements, and staffing.

Job Description

ESSENTIAL FUNCTIONS:

Manages the hiring, training, and performance management of all QC personnel.Provides subject matter assistance for LIMS, methods, testing, and validation.Manages QC testing group to achieve compliant testing in a timely manner.Manages Lab investigations and OOSs including remediation of potential compliance concerns.Provides overall leadership to QC group regarding cGMP compliance improvement and enhancement.Studies and improves various Quality processes providing increased efficiency or process flow using Lean Manufacturing and/ or Six Sigma philosophy of operation.Drives Quality consistency through reviewing/revising various analytical methods/SOPs to ensure adequacy with special emphasis on actual utility of methods under normal QC conditions.Works with plant Managers/Supervisors and Quality technicians to address any laboratory concerns regarding quality, safety, methods, procedures, or operations.Acts as a liaison between the lab and manufacturing/ R&D for investigations and to implement special projects, assist with validations, method transfers, or technology upgrades.Works with groups to ensure compliance to EHS and departmental safety requirements and provide proactive leadership toward continuous improvement of safety operations in the laboratory.Ensures key turnaround timelines for customer service and compliance requirements are achieved.Performs as a subject matter expert during customer and regulatory audits.Serves as an Internal Auditor for the site.Serves as LIMS Administrator

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:

Develops and coaches to build talent.Participate in a 5S Workplace System to ensure good housekeeping and organization.Prioritizes and plans workload and team assignments to meet all internal and external customer needs for maximum efficiency and accuracy.Effectively trains others in a positive manner.Other duties as assigned with or without accommodation.

MINIMUM REQUIREMENTS:

Education:

B.S. /B.A. in Physical Science required. 

Master’s Degree preferred.

Experience:

10 - 12 years related experience preferred; at least five years of experience in a supervisory role; strong knowledge of current ­pharmaceutical cGMP requirements

Preferred Skills/Qualifications:

Other Skills/Competencies:

Complete understanding and application of principles, concepts, practices, and standards for testing performed in all QC laboratories

Experience with testing API or Pharma products

Experience leading a group of up to 20 people with 24/7 shift operations

Excellent written and verbal communication and leadership skills

Ability to work in and promote a team environment

Working knowledge of Six Sigma and/or Lean manufacturing tools

Sense of urgency.

Action oriented/drives for results

Excellent communication and interpersonal skills

Team orientation/strong team player

Ability to coach, mentor and teach

Excellent decision making, problem solving and analytical skills

Strong managerial courage

Ability to influence change at all levels of the organization

Detail-oriented with the ability to work under tight deadlines

Excellent conflict management skills

Builds positive relationships with others

Excellent time management and prioritization skills

Excellent technical writing skills

LIMS experience preferred

Knows the difference between managing and leading and when to apply each

Command Skills, Action Oriented, Conflict Management, Customer Focus,

Problem Solving, Priority Setting, Written Communication,

RELATIONSHIP WITH OTHERS/ SCOPE:

Reports to Manager, Plant Quality (Site Head of Quality)Work is performed without appreciable directionDevelops strategic objectives for group managedExercises considerable latitude in determining technical objectives of assignmentCompleted work is reviewed for desired results from a relatively long-term perspectiveBias toward change, management of change, and achievement of resultsContact with FDA as subject matter expert during site inspections and customers during frequent customer auditsRegular contacts include Quality Assurance, Materials Management, Logistics, Marketing, R&D, Site Production Leaders and EH&S.This position has several direct reports, such as Quality technicians and testing Engineers.

WORKING CONDITIONS:

60% normal office and meeting room conditions.40% Laboratory and Plant environment including exposure to raw materials and finished products.Must be able wear the required Personal Protective Equipment (PPE) as deemed necessary by EH&S, leadership team, corporate, or safety guidelines.Some off shift and weekend work can be expected; travel requirements are minimal

DISCLAIMER:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.