Director of Quality Management

Job#: 3023256

Job Description:

Director of Quality Management

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

ESSENTIAL DUTIES/RESPONSIBILITIES/FUNCTIONS:

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.

SUPERVISORY RESPONSIBILITIES:

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.

COMPETENCIES:

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

QUALIFICATIONS & SKILLS REQUIRED TO PERFORM JOB DUTIES:

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.

EDUCATION AND/OR EXPERIENCE REQUIRED TO PERFORM JOB DUTIES:

Bachelor's degree 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

PHYSICAL REQUIREMENTS TO PERFORM JOB DUTIES:

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.

EEO Employer

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, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico. Apex uses a virtual recruiter as part of the application process. Click for more details.

Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.