Position: | VP of Biopharma Product Testing | |
Location: | Harrisburg, Pennsylvania | |
Field: | Life Sciences | |
Position Type: | Full Time |
Summary
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.
Description (Roles & Responsibilities)
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
Requirements (Qualifications)
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)
Additional Details
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 :
- Develop my client's BioPharmaceutical Products Testing business in the US with organic growth of 10%+ while meeting agreed EBIT target objectives.
- Improve operations efficiency of the laboratories. Streamline the operational processes by using LEAN practices and approaches, and by making good use of IT so as to achieve high efficiency. Support the development, implementation and optimal use of the Company’s Laboratory Information Management System and ensure its efficient usage at all levels of the laboratory to improve productivity and profitability.
- Increase cost effectiveness and profitability to meet best industry standards in all activities.
- Take appropriate measures to improve economic profit, including hands-on personal commitment in addressing situations where profit levels are too low or payment terms not adhered to by clients.
- Hire, motivate, develop and retain excellent leaders, meeting preferred personality profile as described in Annex 1.
- Define and agree goals and milestones with the site directors and section managers and ensure goals are defined and communicated to their respective teams. Optimize and refine customer centric Key Performance Indicators (KPIs) to monitor progress. Follow up as appropriate and become hands on if required to ensure achievement of goals.
- Optimize the technical and scientific aspects of the laboratory business units by ensuring the appropriate development and application of new techniques and business processes.
- Leverage the existing multiple site capabilities/capacities of the BioPharma Product Testing Group, along with new acquisitions, to establish my client as a preferred outsourcing partner to the global bio/pharmaceutical companies. Capture significant revenue stream and market share from the leading global companies in this market. Develop strategic relationships with senior bio/pharmaceutical executives, and act as executive sponsor for key customer relationships.
- Work effectively with the leadership and corporate business development team on assessment and due diligence of potential acquisitions.
- Support the marketing and sales process for the group. Regularly attend meetings with key clients, at all levels and develop an in depth knowledge of customer requirements through regular meetings.
- Ensure that cross-selling synergies with other client laboratories are being developed.
- Develop with the management of the company, and fine tune and agree with the Group representative in his/her board, strategies, and a business plan to achieve and/or expand market leadership in all key segments of operation. Implement the strategy as agreed with the representative of his/her shareholder.
- Prepare and propose annual budget and 3 year plan. Report on any deviations to deliver agreed upon results to his/her shareholders.
- Ensure that all operations have appropriate systems, work ethics and policies in place to guarantee high quality of service to clients.
- Guarantee and control that all relevant legal and Health & Safety requirements are being abided to, in all companies or Business Units under his/her direct or indirect responsibility, that the companies accreditations are being maintained and regularly expanded and that all employees act according to client's values.
- Lead according to Eurofins Leadership Charter and act as a role model for leadership and staff.
OTHER ASSIGNMENTS :
- Ensure follow-up to a representative of the shareholder (a member of client's Group Operating Council) on a regular basis and as often as requested.
- Guarantee and control that the Group’s General policies are implemented according to the laws and internal and external rules applicable in the territory, activities and companies under his/her responsibility.
PERFORMANCE APPRAISAL CRITERIA :
- Achievement of organic growth and profitability expectations.
- Increase of profitability of the companies and business units under his/her responsibility.
- Achievement of market position and revenue growth with large bio/pharmaceutical companies.
- Improvement / success on agreed upon KPIs and projects.
- Optimization of the internal processes and implementation of LEAN practices to achieve operational excellence.
- Recruitment/development of highly successful leaders for the long term leadership of each Eurofins Business under his / her responsibility.
- Increase awareness of company and develop its image as quality and technology leader in the US market.
REQUIREMENTS:
- Approximately 10 years of professional experience. At least 3 years of these with full responsibility for P&L (of a business with at least 100 staff and sales > 20 M€ / year) and proven financial success, preferably in the business services sector or in a small / mid-size company operating in a very competitive / low margin sector.