Position: | VP of Biopharma Product Testing | |
Location: | Harrisburg, Pennsylvania | |
Field: | Life Sciences | |
Position Type: | Full Time |
Who We Are
At my client about 80,000 people across 150 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. A member of the company, A well known biotech copmany has been at the forefront of the biotechnology industry for more than 30 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. The headquarters for Roche pharmaceutical operations in the United States, My biotech client has multiple therapies on the market for cancer and other serious illnesses. Please take this opportunity to learn about my client, where we believe that our employees are our most important asset and are dedicated to remaining a great place to work.
Head, Quality Biologics Drug Substance Manufacturing
Leadership and influencing inter-organizational operations. Ensures cGMP compliance is maintained and enhanced across seven (7) sites in Asia, Europe and United States. Active participant on Biotech GMP core team. Manage approximately 1,000 employees. Direct line accountability for all individuals to include QA/QC/QS/QE. Responsible for the Quality of all biotech products (to Genentech and FDA/EU/Japanese/ROW standards); successful inspection results for biotech facilities and laboratories in the Biopharmaceutical network. Ensures realization of my client's Quality and Compliance requirements, philosophy and standards, as well as execution of strategic plans. Works collaboratively with Biopharmaceutical Manufacturing leadership team to ensure goals are met and strategy and objectives are achieved.
Strong functional knowledge of: Analytical methods and manufacturing processes; Regulatory requirements; Quality Assurance systems; regulations required for all biotech functions; business acumen; experience in the science of Quality and Compliance; contract negotiations and legal liabilities; risk management; change management; facility startup and approvals.
Leadership & Other Key Behaviors: Building and leading teams; business knowledge; collaboration and teamwork; communication; developing self and others; strategic agility; communication; talent management/development; decision making. Operational unit decision-maker for: lot disposition, compliance strategy/priority, compliance position, response to regulatory agencies for observations, etc, strategy design/focus, organization design, talent management, Quality and Compliance priorities.
MAJOR RESPONSIBILITIES:
Quality Operations Management for Biotech Commercial Manufacturing Direct accountability for Quality and Compliance activities and organization across the Bioopharmaceutical Drug Substance Manufacturing network to include: product testing (QC), product assessment and release (QA), Quality auditing and inspection readiness, product quality management and implementation of the Quality System at Manufacturing Site level.
Inspection Readiness
Accountable for ensuing proactive site cGMP inspection readiness programs are established and operational to include allocation of the necessary resources to successfully execute the program throughout the Biopharmaceutica
manufacturing network.
Product Quality Management
Accountable for product quality management activities at site level to include product test and disposition, change management, investigation and CAPA management, product field performance (complaint management) and product
performance trending and reporting in Biopharmaceutical manufacturing network.
Product-wide Risk Management
Responsible for end-to-end Product Quality Risk management, as well as proactive management of Quality and Compliance related risks across Drug Substance Biopharmaceutical operations. Ensure risks are managed to ensure our right to operate and quality supply to patients.
GMP Surveillance and Education
Responsible for ensuring GMP surveillance information and processes are deployed across network which provide proactive GMP compliance and education.
External Relations
Responsible for providing Quality input to Global Quality organization and establishing working relationships with global regulatory authorities and key industry groups in coordination with, and as defined by, Head of Quality Biotech Operations with a goal to develop sound GMP requirements for the pharmaceutical industry.
Organization and Resources
Directly responsible for organization design and implementation to include staffing, talent management, budgeting and resource allocation.
Budgeting and Financial Performance
Responsible for managing to Financial Operating Targets as set for the Biochemical Quality organizations.
Who You Are
Expert in Quality and Compliance principles and requirements.
15+ years in pharmaceutical Quality and Compliance or related operational leadership roles.
Education should include minimum BS degree. MS, chemistry, biology engineering, or other science preferred.
Established track record of Quality and Compliance decision-making.
Established track record of successful regulatory inspections.
Experience managing a network of operations.
Internatonal experience preferred.
Experience in multiple technical platforms (bio, pharma, device, aseptic processing)
OVERALL OBJECTIVES: Lead and expand my client's BioPharmaceutical Products Testing activities in the US by executing the agreed upon strategy. Exceed business expansion and profitability goals.
SPECIFIC ASSIGNMENTS :
OTHER ASSIGNMENTS :
PERFORMANCE APPRAISAL CRITERIA :
REQUIREMENTS: