Manager, Supplier Quality Assurance
We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.
I. JOB SUMMARY
The Manager role supports the state of compliance at the Camden & MDCW facilities through leadership of the Supplier Quality Management program at the site level. Interacts with Supply Chain and Client Portfolio Management teams as relates to suppliers of raw materials and components for the CDMO business.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Supplier Quality Management
o Partner with Supply Chain and Global Supplier Quality to execute supplier scorecard program
o Evaluate new supplier requests and maintain the Approved Supplier List to ensure supplier information is up-to-date and accurate
o Identify the need for site level Supplier Quality Agreements, track and initiate their renewal
o Site Process Owner for Veeva Supplier Quality module
o Responsible for working with the purchasing department and collaborating on supplier corrective actions requests (SCARs) as needed for non-conforming materials
o Follow up with supplier to ensure implementation of appropriate CAPAs identified through SCAR process
• Material Management
o Ownership of material specifications
o Perform/support performance of elemental impurity and EU risk assessments, upon request
o Manage the assessment of supplier change notifications related to local suppliers
• External Supplier Audits
o Communicate with Global Supplier Quality team to monitor schedule and execution of audits of suppliers supporting the Camden and MDCW facilities
• Material Review Board leadership
• Monitor and report on department metrics to site and global leadership
• Ensure that site procedures related to supplier quality management are aligned with global policies
• Support other activities within the QA department, which may include providing compliance metrics for site and corporate management, supporting regulatory inspections, client audits, annual product reports and other quality or regulatory activities as needed
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 from an accredited university or college
• Minimum of 8 years’ experience in a biopharmaceutical, medical device, or life sciences manufacturing organization
• 3+ years experience in a Supplier Quality Assurance role
• Previous leadership experience preferred
• Demonstrated success in independent judgment, technical proficiency and collaboration with others in a cGMP environment.
• Must be a team player and able to work cross-functionally in a matrixed environment.
• Must have excellent written and verbal communications skills.
• Excellent organizational and interpersonal skills.
• Ability to work as part of a high performing team and collaborate effectively with staff at all levels, and across all functions
• Demonstrated ability to manage multiple activities while maintaining a high level of organization
• Demonstrates initiative; ability to undertake additional responsibilities and respond to situation as they arise with little or no supervision
• Ability to make independent sound decisions and independently manage priorities in alignment with department and company goals
IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
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.
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