Sr. Manager of Quality Assurance at Great Falls

Job Description

Partial Job Description
1) Direct the quality assurance staff and functions
2) Provide regular performance feedback, development and coaching for direct reports
3) Ensure decisions made meet external and internal regulatory compliance expectations for company products
4) Communicate and coordinate with other departments and customers as required for quality related issues
5) Manage the review and approval of Production Batch Records and QC testing records for final product release
6) Ensure quality systems are compliant and efficient
7) Manage customer and FDA audits and the PAI preparation
8) Take responsibility for elaboration of regulatory company strategies to support development and lifecycle of drug products in USA, EU, emerging countries and ROW
9) Take responsibility for change control request assessment with regards to European requirements
10) Take responsibility for crisis management and communication with Boards of Health for regulatory, compliance and supply issues
11) Take responsibility for definition and management of worldwide quality systems for development and commercial pharmaceutical activities
12) Manage Global Regulatory and Quality activities for the facilities in USA and China
13) Be responsible for management of inspections by Health Authorities (FDA)
14) Manager elaboration of regulatory strategies for worldwide submissions (clinical trials and commercial uses of drug products)
15) Act as a key player and regulatory/quality representative in discussions and negotiations with major pharmaceutical companies
16) Help to draft and update annual DMF documents
17) Implement and train the employees on Risk Assessment

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Job Requirements

Qualifications / Skills Required
1) BS in a Scientific or Technical discipline
2) Master?s degree (preferred)
3) Minimum 15 years of experience in Pharmaceutical, Biotech or related industry
4) Minimum 5 years of experience in Quality Assurance
5) Experience in regulatory submission of drug products in USA and Europe
6) Previous management or project experience
7) Extensive knowledge and experience in cGMPS
8) Ability to change the thinking of or gain acceptance of others in sensitive situations
9) Excellent communications skills, both written and verbal
10) Strong interpersonal skills

Country: USA, State: South Carolina, City: Great Falls, Company: Sterling Life Sciences.