Director, QA Compliance & Supplier Quality
Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.
The Director of Quality Assurance (Compliance) provides Compliance oversight for all aspects of process development, commercial manufacturing, testing and disposition of product, materials and components. This position is the owner of the Internal and External audit program at the site, the Annual Product Review (APR) program and the Supplier Quality Program. This position will also support Adverse Events investigations as needed and the BPDR process among other tasks.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Direct Compliance oversight for the Canton site regarding SOP and Regulatory compliance and Supplier Quality auditing functions.
• Participate and work cross functional with the Global QA group on drafting and implementing new global standards.
• Represent Quality Assurance and Emergent during FDA and other regulatory agency inspections as well as customer relation activities with CDC, BARDA, DoD and HHS
• Complete FDA inspection response reports, monthly response updates and coordinated response and gap analysis teams
• Present to the Senior Leadership Team and site on audit readiness program
• Support Global Supplier Quality program and external vendor auditing requests
• Manages and owns the Quality Management Review Meetings
• Communicate metrics, trends, and data summaries to senior management using a variety of media: intranet, reports, and presentations
• Identify opportunities for continuous improvement in compliance, business, and safety practices; then plan and implement improvements
• Manage employees with various experience levels with capability to develop new leaders, individual contributors, and technical experts
• Conduct performance reviews, develop and administer development plans, follow-up on personnel issues, and provide feedback to group
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
• Bachelor’s degree in Biological Science or similar science
• Minimum of 10 years of pharmaceutical or biotechnology (Large Molecules) cGMP Quality experience with increasing responsibilities
• Previous experience in management of quality systems and Quality department.
• Minimum of 8 years of supervisory experience preferred
• Previous experience working with FDA (CBER) and participating in regulatory agency inspections
• Must have SOP, investigation, and project protocol writing skills and demonstrated ability to critically evaluate content of such documents
• Must be able to partner with others and have the ability to influence without authority across cross-functional organization
• Must have excellent verbal skills. The ability to communicate clearly and engage in dialogue with all levels of employees.
• Must have good written communication skills. The ability to tailor communications to all levels in department and prepare appropriate updates to senior management and executive management
• Must be able to prepare reports for internal metrics and technical content; and prepare reports and data summaries for FDA review. Must determine appropriate content and criticality of information
• Must be able to critically evaluate data summaries and conclusions.
• Must possess cGMP knowledge across all QA functions
• Must have a full competence of cGMPs, 21CFR210, 211, ICH, USP-NF, and Aseptic Processing Guidelines
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.