Manager, Quality Assurance
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.
I. JOB SUMMARY
The Manager, Quality Assurance, is responsible for ensuring the site maintains its compliance to the global quality standards. This is managed by auditing site procedures against the global quality standards and maintaining current good manufacturing practices against industry guidelines. The Manager has oversite of the quality systems and the quarterly management review. The Manager will report directly to the Director of Quality and will maintain a team that functions in maintaining Training (electronic and instructor led), Document Control & Archiving, and client relations. The Manager will also take a lead role in audits conducted by clients and regulatory agencies.
They apply expertise and regulatory knowledge to support change and risk management, including application of scientific and technical innovation as it pertains to Commercial Manufacturing. The Quality manager develops a lifecycle and systems-based approach to the design and implementation of Commercial Quality Systems and process controls. They recommend solutions to site leadership on cross functional issues. Frequently interacts with senior leadership, direct manager, peers, internal customers, external clients and other cross functional peers across Emergent to gain alignment on sound quality decisions.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Manage QA oversite for quality systems; including investigations, document control, change control, inspections (internal and vendor).
• Manage Quality shop floor team; work closely with manufacturing team and manufacturing science & technology team to work collaboratively to ensure compliance to regulatory guidelines.
• Liaise on occasion between internal Global project team and external customers.
• Represent the department in interactions with internal functional units and external contract partners or regulatory officials.
• Manage and Coach employees at various experience levels and provide guidance on compliance and regulations. Provides feedback as needed. Act as advisor to the unit and resolves problems to meet customer needs and scheduled timelines.
• Create/review various types of documentation to ensure completeness, accuracy, and compliance including but not limited to regulatory submissions, product complaints, annual product reviews, APR’s, Quality Agreements, Supplier Notifications, Request For Proposals, SOPs, master plans, deviation investigations, CAPAs and change controls
• Establish, implement and maintain quality management systems to measure and control quality in the production process.
• Exercise judgment within defined site procedures to determine appropriate action for resolution of technical issues.
• Receive assignments in the form of objectives and organizes resources to promote and achieve department goals.
• Review/support contract negotiations for potential customers (specific to review of sections pertaining to compliance)
• Participate in company sponsored training and provide training to new team members.
• Lead implementation of strategic plans and support department Operational Excellence Projects
• Communicate on Department behalf when needed.
• Lead key Quality meetings and cross functional teams.
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.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
• Bachelor’s Degree in Scientific or related fields required
• A minimum of eight (8) years of cGMP Quality experience with minimum 1-2 years’ experience leading a team or having direct reports.
• Strong Commercial manufacturing experience (Large Molecules) required
• Quality Auditor, Six Sigma, or equivalent certification/education preferred
• Experienced with US, EU and Canadian pharmaceutical regulations, ISO standards
• Expert Knowledge and application of GMP principles
• Excellent communication skills: oral/written and listening
• Personal Competencies: Self-awareness, Integrity, Judgment, Vision, and Adaptability, decision making, coaching,
• Interpersonal skills: team building, consensus building, conflict resolution
• Critical analytical skills, strong verbal and communication skills
• Ability to work under pressure and analyze processes within scheduled timeframes
• Ability to work independently in conducting quality system and process audits.
• Proficiency using PC software programs, including PowerPoint, Excel, Word, Outlook, Internet Explorer, Access, and Visio.
• Excellent presentation skills, including written and verbal communication skills
• Serves as a change agent for continuous improvement within the scope of work.
• Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
• Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
• Proficient in SAP and Technical Writing
IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
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.