Senior QA Manager

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    "requisitionDescription": "<div><table border=\"1\" cellpadding=\"0\" cellspacing=\"0\" id=\"isPasted\" width=\"720\"><tbody><tr><td valign=\"top\" style=\"width: 20.1669%;\"><p><strong>Position Summary</strong></p></td><td valign=\"top\" style=\"width: 79.8331%;\"><p>The Sr. QA Manager implements cGMP and regulatory requirements at BSM. &nbsp;The Sr. QA Manager is responsible for maintaining and improving the Quality Culture at BSM and providing leadership to the rest of the GMP team in this regard.</p></td></tr><tr><td valign=\"top\" style=\"width: 20.1669%;\"><p><strong>Duties and Responsibilities</strong></p></td><td valign=\"top\" style=\"width: 79.8331%;\"><ul><li>Develop, implement, manage, audit and maintain quality systems to support clinical and commercial and development activities at BSM</li><li>Oversee material lot release activities including specifications&nbsp;</li><li>Oversee the Excursions program</li><li>Oversee the Disruption to Controlled Environments (DCE) program&nbsp;</li><li>Assist with Quality System Events (deviations, OOS, CAPA, Change Control, etc.) and chair MRBs</li><li>Provide oversight of Quality Control Microbiology activities</li><li>Assist with vendor qualification and regulatory audits</li><li>Assist with the internal audit program</li><li>Ensure that cGMP requirements and quality standards are recognized, understood and maintained</li><li>Ensure in-process and finished products and processes conform to in-house policies and procedures as well as other applicable regulations and guidelines</li><li>Work across all disciplines (e.g. manufacturing, quality control, warehouse and engineering) to ensure that a state of audit readiness is maintained</li><li>Keep abreast of changes to quality regulations and guidelines and advise the management team of any business implications of these changes</li><li>Provide quality guidance to development of analytical methods</li><li>Provide quality guidance to product development projects and programs</li><li>Other duties as assigned</li></ul></td></tr><tr><td valign=\"top\" style=\"width: 20.1669%;\"><p><strong>Regulatory Responsibilities &nbsp;</strong></p></td><td valign=\"top\" style=\"width: 79.8331%;\"><ul><li>Conduct business in a responsible manner that complies with all state, OSHA, and HIPAA regulations</li><li>Maintain a detailed and comprehensive understanding of FDA, EU, and other regulatory agency requirements</li></ul></td></tr><tr><td valign=\"top\" style=\"width: 20.1669%;\"><p><strong>Supervisory Responsibilities</strong></p></td><td valign=\"top\" style=\"width: 79.8331%;\"><ul><li>Manage quality activities at BSM &nbsp;</li><li>Provide leadership to the GMP team related to Quality Culture</li></ul></td></tr><tr><td valign=\"top\" style=\"width: 20.1669%;\"><p><strong>Experience</strong></p></td><td valign=\"top\" style=\"width: 79.8331%;\"><ul><li>Five (5) to ten (10) years&rsquo; experience working in a cGMP environment</li><li>Five (5) years&rsquo; experience in a Quality role&nbsp;</li><li>Three (3) to five (5) years&rsquo; experience supervising individuals in a cGMP environment</li></ul></td></tr><tr><td valign=\"top\" style=\"width: 20.1669%;\"><p><strong>Education</strong></p></td><td valign=\"top\" style=\"width: 79.8331%;\"><ul><li>Bachelor&rsquo;s Degree</li><li>Relevant experience may be substituted for degree</li></ul></td></tr><tr><td valign=\"top\" style=\"width: 20.1669%;\"><p><strong>Knowledge, Skills &amp; Abilities</strong></p><p><strong>&nbsp;</strong></p></td><td valign=\"top\" style=\"width: 79.8331%;\"><ul><li>Skilled in the use of Microsoft office applications (Word, Excel, PowerPoint) and Adobe Acrobat</li><li>High attention to detail</li><li>Good writing, public speaking and presentation skills</li><li>Must be able to travel approximately 10% of the time</li></ul></td></tr><tr><td valign=\"top\" style=\"width: 20.1669%;\"><p><strong>Physical Requirements</strong><strong>&nbsp;</strong></p><p><strong>&nbsp;</strong></p></td><td valign=\"top\" style=\"width: 79.8331%;\"><ul><li>Ability to sit for prolonged periods of time</li><li>Ability to stand for prolong periods of time as required</li><li>Able to lift up to 10lbs</li></ul></td></tr></tbody></table></div>\n",
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