Summary:
Provides technical leadership and Quality oversight in association with specific aspects of Quality to ensure compliance with regulations that govern pharmaceuticals. Ensures the Company can operate without regulatory actions that impede product quality, cause product stoppages or reduce customer satisfaction.

Essential Functions:

1. Complies with all job-related safety and other training requirements. Works in a safe and responsible manner in order to create an injury-free and incident-free workplace.

2. Processes and projects of moderate complexity, perform compliance assessments, make decisions regarding regulatory requirements, write new procedures and ensure adherence to current regulations.

3. Ensures quality of methods, processes, materials and products by providing coordination and review of group operations, staff training, and the assessment/improvement of systems and processes.

4. Conducts risk assessments and take appropriate actions during quality system management and oversight activities (e.g. during review/approval) to ensure adequate controls in relation to the level of product quality, safety and business risks.

5. Acts as a technical resource for support of systems and new product introduction by proactively interpreting regulatory and compliance requirements, establishing and maintaining systems.

6. Performs Quality Assurance (QA) batch disposition (release) decisions.

7. Performs other duties as assigned.

Education:

Bachelor’s Degree in a scientific or related field is required.

Experience:

Four years of experience in the pharmaceutical industry preferred and should include leadership roles on high level projects.

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies:

Makes decisions while taking into account level of risks using written guidance in regards to compliance and product quality. Can lead projects of moderate complexity in scope to implement procedures and processes to meet changing regulations. Familiarity with a variety of concepts, practices and procedures. Outstanding attention to detail and organizational skills. Self-starter, mature, independent and dependable. Ability to work in a fast paced environment under pressure, able to multi-task and is results-oriented. Demonstrates ability to maintain a high degree of confidentiality. Effective time management and prioritization skills. Requires discretion and independent judgment. Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters. Highly effective verbal and written communication skills.

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.  

Disclaimer:

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.