Objective:

This position requires the incumbent to serve as an integral part of the senior management team involved in strategic decision making and compliance with regulatory bodies.

 

Essential Job Duties:

• Creates a quality organization and systems that will provide Apicore with a competitive advantage in the market place
• Provides effective leadership and direction for the quality programs throughout Apicore’s manufacturing operations on a global level
• Provides structured review processes to report data on a monthly/quarterly basis to the CEO and Board of Directors
• Directs efforts to ensure efficient and effective deviation, CAPA, training and document control systems are maintained and continuously improved
• Serves as a key and active member of the team to ensure business objectives are aligned and that Apicore is performing to its operational objectives
• Leads, influences, creates and works within cross-function team environments
• Works on multiple projects simultaneously and adapts to fast-changing business priorities
• All other duties as assigned

 

Experience & Education: Minimum Bachelor Degree Required. Experience in manufacturing and quality control experience with APIs and formulation.

 

Knowledge: Knowledge of cGMP (FDA/EU and ICH) requirements and the ability to assess compliance risks. Extensive experience in regulatory inspection management programs and participation in regulatory inspection audits.

 

Skills & Abilities:
• Ability to work independently with little to no supervision
• Excellent leadership skills
• Exceptional oral and written communication capabilities
• Advanced computer knowledge in MS Office programs
• Excellent organizational abilities and superior attention to detail
• Must have high level of interpersonal skills
• Ability to maintain high level of confidentiality at all times
• Possesses strong analytical and problem solving skills
• Excellent time management skills and project management skills
• May be required to sit, stand, walk regularly and lift, push, pull up to 50 pounds continuously

 

Working Conditions: Position will be mainly office and warehouse based with a clerical component in addition to physical requirements. Incumbent will be working in a laboratory and manufacturing facility and will be exposed to these environments. Minimal travel required.