Director of Quality Management

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The Director of Quality Management is responsible for the overall performance of the quality assurance and quality control systems in adherence with regulatory standards.

• Responsible for the continuous improvement and management of the integrated Quality Systems of the Company.
• Maintain the Quality Management System by overseeing key processes and activities such as the inspection process, nonconforming materials process, internal and external audits, Corrective and Preventative Action investigations, and change control for documents, processes, and products.
• Promote the development of a company-wide culture of quality excellence and understanding of the key elements related to the quality systems.
• Ensure that Company facilities are in compliance with all products and the food and drug regulations that pertain to the operation.
• Analyze appropriate procedures and corresponding practices and recommend and direct strategies for regulatory compliance.
• Conduct internal audits of facility for quality control practices and ensure that the practices are compliant to documented process and applicable regulations.
• Audit external partnerships for quality control practices and process compliance to documented process of record and applicable regulations.
• Ensure action plans are implemented and maintained through follow-up inspections, internal audits, and checks.
• Coordinate ISO conformance audits of Quality Management System, by serving as the ISO Management Representative.
• Approve Company SOPs for the Quality Management Departments.
• Comply with Company SOPs and policies.
• Maintain knowledge of existing regulations, standards, or guidance documents.
• Work under applicable regulatory guidelines.
• Assist with technical matters.
• Coordinate GMP & food conformance audits, by serving as the GMP/FSMA management representative.

• This position supervises employees in the department and is responsible for the performance management and hiring of employees within the department.
• Execute performance management to include planning, monitoring, reviewing and evaluating performance of personnel.
• Provide constructive feedback and conduct performance reviews to direct reports.
• Enforce company policies.
• Additional duties may be assigned as needed.

• Adaptability
• Collaboration skills
• Communication proficiency
• Customer/client focus
• Decision making
• Delegating
• Interpersonal skills
• Leadership
• Listening
• Managing
• Negotiation
• Organizational skills
• Performance management
• Problem solving/analysis
• Stress management
• Team building
• Verbal expression
• Written expression

• Ability to read, speak, and write in English.
• Computer proficiency:
  Microsoft Office.
• Knowledge of basic office procedures.
• Ability to maintain employee information confidential.
• Extensive knowledge of GMP Industry regulations, and ISO 9001 standards.
• Knowledge of Quality management tools, statistical process control, regression analysis, and statistical sampling methods.
• Thorough knowledge of audits and audit procedures.
• Detailed knowledge of document and change control processes.
• Proficient knowledge of FSMA, and the proven ability to write FSMA plans.

• Bachelor's degree in a scientific or technical field from an accredited college required.
• Graduate degree preferred.
• Minimum 5 years' experience in GMP-regulated industry with experience conducting GMP internal audits.
• Minimum 5 years' experience in managing Quality Management systems activities such as document and change control, quality systems auditing, supplier management, raw material or finished product inspections, and nonconforming or out of specification review processes.
• Minimum 2 years of work experience with ISO 9001 Quality Systems.
• Previous experience in pharmaceutical or similar manufacturing environment preferred.
• Must have experience of ALCFR part 111.

• Stand/remain upright up to 4 hours at a time to perform audits.
• Stand/remain upright up to 4 hours at a time to perform audits for up to 4 consecutive days.
• Sit up to 4 hours at a time to process paperwork or research regulations.
• Use keyboard and computer.
• Reach forward and overhead, kneel, twist, turn and bend.
• Visual acuity skills, needed to distinguish color, fine lines, and nonconformities in products and materials.
• Travel 10% of the time to domestic and some international locations for audits and project follow up.

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation,…