Manufacturing Compliance Supervisor
- Emergent BioSolutions
- Baltimore (Bayview), MD
- Start date
- Feb 4, 2023
- Manufacturing & Production, Manufacturing/Mechanical, Regulatory, Legal/Compliance
- Required Education
- Bachelors Degree
- Position Type
- Full time
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 Manufacturing Compliance Supervisor position reports to the Sr. Manager of Manufacturing Compliance at Emergent Manufacturing Operations Baltimore (EMOB).
- The position is responsible for Batch Release, CAPAs, Change Controls, Deviations and Root Cause Analysis. This includes supervision of analyst staff, manufacturing budgets, developing standard operating procedures and training, interacting with other departments.
- Provides hands-on supervision of manufacturing staff, analysts in the operation of running root cause analysis meetings and writing and reviewing deviations.
- Maintains performance standards and goals for Manufacturing Analysts
- Demonstrates and enforces understanding and adherence to Emergent policies, GMP standards and safety procedures
- Hires, evaluates, trains, and develops staff.
- Oversees development and maintenance of management processes including, but not limited to: Employee job descriptions, Integrated Performance Management Process (IPMP) documentation, staffing models, resource allocation models.
- Effectively delegate decision making into the department. Empower direct reports to make level-appropriate decisions.
- Updates the Sr. Manager of Manufacturing Compliance on process status and achievement of objectives
- Resolves problems of analyst staff and manages analyst resources
- Interacts with other site group leaders including Sr. Director and VP level staff
- Prepares and conducts technical presentations of manufacturing processes
- Performs annual performance appraisals of staff reporting to the position
- Generate Deviations, SOPs and Protocols as required
- Works with subject matter experts to find root causes for minor, major and critical deviations, CAPAs and Change Controls
- Maintains metrics for all Deviations, CAPAs, Change Controls, Batch review, and annotation resolution.
- Supports Emergent QA during audits and regulatory inspections
- Supports other manufacturing process teams and other EMOB groups as necessary to achieve Manufacturing team goals
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.
EDUCATION, EXPERIENCE & SKILLS
- BS degree in biology, chemistry or related scientific or engineering field
- Minimum 4 years of Root cause analysis and OE methodology preferred; Hands on experience leading root cause analysis meetings.
- Computer literate (Word, Excel, Smartsheet and PowerPoint)
Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.
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.
Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what’s most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information visit www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter.
Stock Symbol: EBS
400 Professional Drive
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