Dir, Quality Assurance

POSITION SUMMARY

 

 

Provide a brief description of the general nature of the position; an overview of the purpose and objective of this position and reporting relationships. (Why does this job exist)

 

Management of Quality Assurance functions across the Wilmington, Ohio site. Ensure that the site operates in compliance with FDA, EU and all other regulations as required, and remains inspection ready at all times. Interface with FDA, other regulatory agencies, customers and consultants. Liaise with corporate functions across the company. 

 

MAJOR RESPONSIBILITIES

 

Major Responsibility Percentage of time spent on each responsibility List the primary job duties for the role Estimate a percentage of time spent on each activity (Must add to 100%)

• Primary decision maker on matters impacting the quality assurance function.  Responsible for improving and maintaining policies, procedures and standards.

25

• Ensure that department is staffed appropriately and the required initial and continuing education of personnel is carried out and adapted according to need.

25

• Responsible for oversight of batch review, line clearance, quality on the floor activities, general manufacturing services, qualification review, product release and clinical release.

25

• Management oversight of Quality systems – deviations, product and process investigations, product complaints, change control, internal audits compliance risk, audit readiness, data integrity and supporting management tools. Operate in compliance with applicable Quality Agreements.

25

 

QUALIFICATIONS

 

• Team Player committed to quality; motivated self-starter; detail and results oriented; Well organized, efficient worker with little supervision required; innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks.
• Good communication skills (written and verbal) at all levels of the organization.
• A leader of people who uses influence, coaching skills, collaboration and persuasion to accomplish objectives in a cross-functional team environment.
• Experience with  FDA regulated pharmaceutical manufacturing site 
• A thorough working knowledge of regulatory compliance, process validation, technology transfer, plant engineering and competent software skills. 
• Able to grasp complex technical issues and make appropriate compliant decisions based on data and information from various sources.
• Expert knowledge of Quality Operations in a pharmaceutical manufacturing environment.
• Parenteral experience is essential, solid oral dosage experience is an advantage.
• Experience in developing and implementing a CGMP compliance program in association with bringing a product through clinical trials to commercialization.
• Contribute to the continuous improvement of site and company Quality Management Systems and processes through participation in the Extended Quality Leadership Team.

EDUCATION AND EXPERIENCE

• Minimum education Bachelor of Science degree
• 15years experience in the Pharmaceutical Industry with progressive Quality leadership responsibilities. .
• Significant managerial role in Quality (at least 5 years).

WORKING CONDITIONS

This position is expected to be flexible in work hours to meet the business needs, is an on site role and may require occasional travel .

PHYSICAL REQUIREMENTS

There are no special, physical requirements for this position.

                                                                                  

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Why join Team Alkermes?

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquarter