POSITION PURPOSE

A brief summary of the purpose this position must fulfill.

 

Serve as the site’s quality head and ensures regulatory compliance for 21 CFR 210 and 211 Current Good Manufacturing Practice in Manufacturing, Processing, Packaging of Drugs, 21 CFR 4 Regulation of Combined Products. Oversees Quality Compliance, Quality Operations and Quality Control functions. 

 

Perform job functions in accordance with all applicable Standard Operating Procedures (SOP), federal and state laws, Occupational Safety and Health Administration (OSHA) guidelines, health authority regulations, and departmental processes.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must satisfactorily perform each essential duty.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

 

  1. Serve as the site’s Management Representative to authorize quality system and quality management changes.

 

  1. Ensures the quality system requirements are effectively established and maintained, reports the performance of the quality system to execute Quality Management.

 

  1. Provides organizational leadership and management oversight to the Quality department.

 

  1. Serve as the site’s Quality representative host for health authority / regulatory agency audits and inspections.

 

  1. Ensure the compliance to Global Quality policies.

 

  1. Coach, develop and identify staffing needs for the quality department.

 

  1. Oversee the sites cGMP training, stability and validation programs.

 

  1. Manage off-site contract manufactured products and CDMO quality business relations.

 

  1. Prepare and administer department budget.

 

  1. Perform other duties as assigned.

 

 

QUALIFICATIONS

The qualifications listed below are representative of the minimum knowledge, skill and /or ability required.

 

KNOWLEDGE

Must possess knowledge of regulatory compliance for 21 CFR 210 and 211 Current Good Manufacturing Practice in Manufacturing, Processing, Packaging of Drugs, 21 CFR 820 Quality System Regulation of Medical Devices, 21 CFR Part 4 Regulation of Combination Products.

 

 

SKILLS AND ABILITIES

Must possess strong verbal and written communication skills, interpersonal skills, management/organization skills, strong work ethic, consensus gathering skills, and multi-tasking to meet departmental priorities and goals.  Must have a professional and cooperative attitude.

 

SUPERVISION

Position functions autonomously.  Position directly supervises employees. Carry out management responsibilities in accordance with the organization's policies and applicable laws.  Responsibilities include interviewing, hiring and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

 

EDUCATION/EXPERIENCE

Minimum of a Bachelor's degree (or equivalent) and 10 years of experience. Master’s degree in science preferred. However, a combination of experience and/or education will be taken into consideration. Minimum of 5 years supervisory and/or management experience. Five years of compliance auditing experience. Experience in the pharmaceutical industry within a cGMP (Drug and Medical Device) environment required.

 

LICENSES/CERTIFICATIONS

Certification as an auditor is desirable.

 

LANGUAGE SKILLS

Ability to read and write using the English language.  Ability to read and interpret complex business and/or technical documents.  Ability to write comprehensive reports and detailed business correspondence.  Ability to work with groups of people such as other departments and communicate known and ambiguous concepts.  Ability to present to a group of departments.

 

MATHEMATICAL SKILLS

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions and decimals.  Ability to compute rate, ratio and percent and to draw and interpret bar graphs.

 

REASONING ABILITY

Ability to solve problems with complex variables though non-standardized solutions that require some ingenuity and analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve moderately complex problems.

 

PHYSICAL DEMANDS

The physical demands describe here are representative of those that must be met by an employee to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.

 

Typically sitting at a desk.  Intermittently sitting, standing, walking or stooping.  Requires periodic travel.  May be required to stand; walk; stoop; bend; kneel; and climb steps. May require use of hands and use of arms.  Light lifting requirements. 

 

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.

 

Normal office situation with time spent in the laboratory and manufacturing environments.