Quality Assurance (QA) Manager III Job in Woburn, Massachusetts US
Responsible for the development, implementation and maintenance of Quality Assurance systems and activities. Ensures all relevant quality and regulatory requirements are met for production, and ensures site compliance with quality system regulations issued by FDA, MHRA and other applicable regulatory bodies where clinical or commercial products are in use. Responsible for the evaluation and assurance that appropriate Quality Systems are in place at approved vendors and suppliers supporting GXP activities at Woburn in the US. Develops and manages the QA staff performing release and compliance functions.
Key Responsibilities:
? Oversees compliance and manufacturing QA functions ensuring the establishment, implementation and maintenance of Quality Management Systems (QMS) in accordance with applicable standards established by FDA, MHRA, and other regulatory bodies.
? Oversees and provides direction for the Quality Assurance release and compliance staff at Woburn, and ensures QA functions are performed effectively. Manage QA Document Control staff in Woburn.
? Oversee Woburn compliance and Quality systems: audits, vendor qualification, change control, deviation and investigation management, corrective and preventive action systems, product release.
? Interface with internal customers in Product Development, Quality Control Labs, Manufacturing, Engineering, etc.
? Oversees or facilitates QA interactions with external vendors such as Contract Manufacturing Organizations, and other service providers to ensure compliance with requirements and GXP quality standards.
? Provide support to Chemistry Manufacturing Controls (CMC) regulatory activities, to facilitate regulatory approval of the Company's manufacturing facility and products.
Other Responsibilities:
? Ensures that Woburn QA staff is appropriately trained on an ongoing basis and have complete training records.
? Sets objectives for and appraises QA staff within the Woburn Quality Assurance Department.
? Represents the Quality Assurance function in Woburn and presents QA achievements and concerns to the Sr. Director, QA, VP, RA QA and other senior management.
? Support Clinical QA activities
? Manages use of QA contractors and consultants to enable initiation and maintenance of Quality systems in Woburn, including evaluation of quality compliance through auditing.
? Drafts, reviews, provides oversight to content, and approves controlled documents which may include but is not limited to product, label, and material specifications, batch manufacturing records, standard operating procedures, validation documents, quality policies.
? Provide input in the establishment and implementation of validation philosophies and strategies for facility operation and process equipment programs to ensure a GMP compliant program.
Educational Requirements:
B.A or B.S. degree in an appropriate scientific field. M.S., Ph.D. or other post-graduate degree is encouraged.
Experience and Skill Requirements:
? 8-12 years experience in relevant Quality Systems, technology and management in a regulated biotechnology, pharmaceutical or diagnostics industry environment.
? Proven leadership in managing and motivating administrative and technical staff with strong awareness of the interface among Quality Assurance, Quality Control, manufacturing operations, and pre-clinical development.
? Appropriate GXP training
? Knowledge of FDA and MHRA guidelines regarding GMPs
? Excellent verbal and written communication skills
