Sr. Manager, Product Quality-Hybrid

at  Emergent BioSolutions

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 Sr Manager position is responsible to provide product quality stewardship of our products from introduction throughout the lifecycle. As the product quality expert, the Sr Manager will build the strategy to proactively minimize product quality risks through early detection and mitigation during product development, technology transfer, commercial operations, and product discontinuation.
The Sr Manager is the Quality liaison between Regulatory Affairs and Operations (internal and/or contract manufacturer) to ensure regulatory compliance of manufacturing and testing processes (including contract labs). The role enables efficient communication and decision making related to the quality of our products.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

• B.S / B.A. degree in biological /chemical sciences, or a related pharmaceutical sciences field or equivalent experience in regulated industry.
• 8 years cGMP experience within quality in a biotech, pharmaceutical, or bio-pharmaceutical manufacturing environment, ideally pre-clinical phases through commercial
• Previous experience working with FDA/ EU and participating in regulatory agency inspections preferred.
• Candidate must exhibit strong interpersonal and collaborative / facilitative skills
• Strong oral and written communication skills
• Ability to work independently and in a team setting with minimal supervision
• Ability to make sound decisions regarding compliance-related issues with minimal supervision
• Strong Leadership, high level of personal/departmental accountability and responsibility

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Proactively manage product quality risks ensuring they are proactively mitigated, actioned, and escalated to senior management
• Assess data trends and provide product quality insights regarding product stability, process monitoring, and other key quality system outputs
• Act as Quality advocate and single point of contact for global program strategy teams to ensure consistent quality approach to GMP manufacturing, testing, release, and regulatory filings
• Act as Quality expert for product quality history through lifecycle
• Maintains Product Quality Monographs and Supply Chain Maps in compliance with investigational product and commercial marketing applications
• Authors Global Annual Product Quality Review, coordinating with leads of contributing chapters, and manages commitments to closure
• Provides lead quality review of CMC sections of Regulatory submissions and response to queries. Facilitates management and closure of post marketing regulatory commitments.
• Lead Stability Review Boards to enable primary Quality oversight of the stability program including ensuring annual commitments are met
• Primary Quality oversight of reference standard program with a focus on ensuring supply
• Facilitates Product Specification Committee
• Supports process lifecycle and analytical lifecycle management initiatives
• Partner with other Quality colleagues on significant product quality impact assessments, particularly for notifications to management, BPDRs, recalls, etc
• Facilitates global changes with respect to the product
• Provides support where needed in the creation of Quality Target Product Profiles and product characterization and comparability assessments in line with regulatory expectations
• Supports Health Authority inspections and compliance

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.