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Job Description

Manager/Sr. Manager QA-GMP

Reporting to the Senior Director of Quality Assurance, the Manager/Senior Manager, Quality Assurance will be responsible for developing, implementing, managing and performing quality assurance functions related to cGMP compliance for both clinical and marketed products. The individual in this role will work with the CMC team to build and maintain quality programs that insure regulatory compliance. This will include conducting audits and reviewing and approving manufacturing, packaging and analytical contractor documents. It will also include performing liaison activities related to regulatory inspections.

Specific Essential Responsibilities:

• Supporting and leading the development, implementation, and maintenance of a CMC-related quality assurance strategy and plan
• Performing internal and external audits to assure compliance with GMP regulations
• Interpreting worldwide manufacturing regulations, guidelines, and GMP practices ensuring compliance and advising senior management on relevant business needs
• Auditing third party contractors’ quality assurance standards and control over process for all types of activities
• Reviewing and performing investigations as required on exception reports, deviations and investigations performed by contractor facilities.
• Generating (and approving on an as needed basis) change control documents and maintains change control files
• Achieving alignment regarding resolution strategies while championing corrective action until fully implemented
• Supporting interactions with regulatory authorities related to manufacturing quality and compliance policies, guidelines, and systems
• Providing QA review of CMC documentation, and other documents submitted to regulatory agencies. Includes reviewing and approving documented manufacturing, packaging and analytical records and notifying contractor sites of document approval
• May assist in designing quality systems and assessing the quality systems of CRO’s, clinical sites, and other clinical vendors,
• Effectively interfacing with internal departments, as well as with groups from the outside that provide services

Job Requirements

Candidate Profiles:

• The position requires 5+ years of experience in Quality Assurance at a biotechnology or pharmaceutical company. At least 3+ years experience in CMC Quality Assurance required
• The minimum education required for holding the position is a BA/BS Degree in a life sciences discipline.
• Expert knowledge and experience in GMP and FDA requirements a must.  Experience working with the FDA, as well as working with ex-US regulatory authorities desired. Knowledge / experience in GCP and GLP is a plus
• Analytical laboratory experience is a plus
• Demonstrated ability to establish and maintain effective communications among and with various departments, e.g. CMC,and Regulatory Groups. Ability to influence by persuasion and not just by positional authority is a requirement, as is the ability to be flexible and supportive to other departments in effectively achieving Quality goals for the Company
• Demonstrated ability to effectively communicate the needs for Quality to CMC team is a requirement
• Demonstrated ability to work with manufacturing and testing sites and other vendors.  Excellent and proven negotiation skills required
• Demonstrated ability and willingness to contribute both as a manager and individual contributer is required.
• Analytical thinking, excellent problem solving skills, concern for impact and ability to explain complicated issues to different levels in the organization
• Excellent verbal and written communication skills a must
• Ability and willingness to travel required (15%-20%)

Compensation: 115-125k

For a confidential consideration, please forward your resume in a Word document to [Click Here to Email Your Resumé]

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