Head Of Quality Management And Compliance--Life Sciences/Healthcare

PSA BDP, a member of the PSA Group, is a leading provider of globally integrated and port-centric supply chain, transportation, and logistics solutions. The company is headquartered in Philadelphia, PA, and employs more than 5,500 people worldwide.
We are a team that celebrates our unique diversity and close-knit community atmosphere. Our core values begin at the very top and span the broad reach of our global community.
We offer dynamic careers for those individuals looking to be a part of something bigger and provide unequivocal opportunities for growth within the organization.
PSA BDP serves over 5,000 customers, including some of the world's leading multinational companies within the chemical, retail & consumer, life sciences & pharmaceuticals, and electric vehicle & industrial verticals.
Head of Quality Management and Compliance—Life Sciences/Healthcare
The scope of the Head of Quality Management and Compliance, includes the definition of quality management system (QMS) processes and architecture (QS structure and supporting IT systems) for PSA BDP. This includes standardized company level policies for all segments/business units and regions to follow. This position provides training, and assessment of the organization to ensure company quality systems and tools are aligned with current regulatory requirements, standards, and industry trends. Implements quality systems to ensure quality and compliance issues are addressed in a timely manner. Identify appropriate actions based on process performance indicators. Provide guidance and support for department staff to ensure functional and departmental goals and responsibilities are met. This role will be the internal audit machine, policing compliance to all regulations, processes, and standards thus protecting the company from risks. The candidate requires significant business quality experience as well as recent experience working with Lifesciences & Healthcare requirements in the international transportation and contract logistics sectors. The Head will report directly to the Head of Operation Excellence and dotted to Head of LSH.
Role Description

• Ensure software used for GxP/CEIV purposes is validated appropriately across PSA BDP using a combination of training, processes, systems, and procedures
• Lead this work with the quality leaders in the regions and businesses to support the overall quality strategy for the company.
• Evaluation of business activities to assess for risks.
• Create, maintain, and implement the standardized quality policies for the company as well as the procedures to align with the standardization strategy.
• Create, maintain, and implement a company strategy of Quality Systems across segments/business units (starting with LSH), regions, and other functions that integrate customer, product, and market requirements
• Develop protocol for quality training by establishing a training programme for the company comprising of ISO, GMP, GDP, RQS, etc.
• Hire, train, and develop members of the compliance team.
• Create department structure and processes for managing the various aspects of compliance and quality management.
• Establish and maintain the operational success of Quality Systems functions, with emphasis on prevention, continuous improvement, and customer satisfaction.
• Develop, implement, control, and drive a quality audit program for suppliers
• Proactively audit processes, practices, and documents to identify weaknesses.
• Develop quality management system that exceeds internal and external customer expectations (starting with LSH)
• Hold operations team accountable to KPIs and necessary safety procedures.
• Continually improving the efficiency and effectiveness of the QMS processes and supporting IT architecture
• Work with the senior leaders to prioritize the strategy for standardization and harmonization of global quality systems.
• Define the backbone of global Quality Management System and the global IT solutions to support the QMS.

Job Requirements
Minimal Experience Required

• A recognized expert with a proven track record of 15 or more years managing and delivering best practices in the quality assurance field in large, complex, global organizations with experience in a large (>$5B) LSP organization with Lifesciences & Healthcare focus strongly preferred.
• Strong technical writing experience required.
• Minimum 10 year of experience in the transportation/ logistics industry
• Minimum of 10 years with relevant supervision in a highly matrixed, global environment
• Articulate with ability to influence others and significantly promote and/or negotiate in situations that involve recognizing and responding to underlying concerns where others need to be persuaded to accept compromised solutions.
• Demonstrated ability in enterprise level goal setting and managing budget, investment, and human capital portfolios, including both in-sourced and out-sourced resourcing models is a plus.
• Strong understanding of QMS to the pharmaceutical and/or medical device industry.
• Ability to work effectively and influence leading decision makers across diverse areas of PSA BDP and manage complex structures.
• Minimum of 15 years directly related to the management and administration of quality assurance, control, systems, regulatory compliance, and/or quality improvement.
• Minimum 10 years of experience in a pharma, medical device, and other regulated field
• Lean six sigma and direct experience developing a QMS program from scratch.
• Excellent problem solver with a proven track record of driving results.
• Strong communicator capable of interfacing at senior levels.
• Must be analytical and able to use data to drive the performance of their team.
• Proven ability to work globally; ability to lead a global team and lead across cultures.
• The incumbent must be capable of building internal and external relationships to develop best in class Quality functions.

Please visit our website: www.bdpinternational.com
*** This is a great opportunity to advance your career! Come join our growing BDP team!***
BDP International - The Employer of Choice
Follow BDP International Career Pages!
Facebook l Twitter l LinkedIn