Remote: Quality Product Supply Lead (232067)

Quality Assurance & Quality Control
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JOB DESCRIPTION:
The Quality Product Supply Lead will coordinate the execution of deliverables required for batch disposition across the various manufacturing stages for multiple Gene Therapy programs. In collaboration with the Supply Chain lead, he/she will be responsible for establishing the timelines and monitoring for adherence to the schedule for continuity of product supply. The individual will partner cross-functionally with Internal and External teams representing Manufacturing, Quality Control, Regulatory, Quality Assurance, and CMC Team Leads to ensure timely execution of batch record review, change controls, deviations, QC testing, and alignment of regulatory strategy timelines. This individual will support and operationalize enhancements to the overall business process for on time batch disposition. The successful candidate must have experience in a biotech or pharmaceutical development environment and knowledge of cGMP quality systems.

RESPONSIBILITIES:
Establish and maintain key partnerships across the CMC organization to ensure an integrated approach to process improvement with a Quality mindset
Develop and deploy business processes and tools to efficiently monitor and effectively drive completion of cross-functional deliverables in support of on time product supply across multiple programs
Perform Quality Operations Excellence assessments or Capability Gap Assessments to define opportunities with multi-functional partners and champion improvements
Identify areas of remediation, improve overall stakeholder experience and drive end to end supply chain efficiencies
Establish standard cycle times for cross-functional deliverables and deliver overall Product Supply Metrics to Sr Leadership

QUALIFICATIONS:
A minimum of a bachelor’s degree is required with 12+ years of relevant project management/quality experience within the Pharmaceutical industry
Experience must include 5+ years of leading cross-functional project management activities within the Pharmaceutical industry, building, managing, and articulating comprehensive, complex, cross-functional plans
Experience in Six Sigma and/or Lean methodologies is required. Certification preferred.
PMP (Project Management Professional) or other PM certification or equivalent a plus.
Knowledge and expertise in current Good Manufacturing Practices (cGMPs) throughout the Product Lifecycle: development through commercialization including technology transfer and PPQ
Ability to lead and get things done through influence versus line responsibility
Excellent multi-tasking, analytical, organization and leadership skills
Ability to communicate clearly and effectively with all levels of the organization
Demonstration of strong collaboration skills

Remote: Quality Product Supply Lead (232067)

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About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
State
Massachusetts
(Remote)

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