Executive Director, Quality

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI. 

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

The Executive Director (Head of Site Quality) for the PCI Philadelphia (PHL) facilities, is responsible for the planning, implementation, sustainment, and continual improvement of the Site Quality Management System (QMS).  This Sr. Leadership role is key to driving and sustaining a culture of quality at the PHL Site to ensure the continuous production of all customer drug-device products are manufactured and packaged consistent with established standards and specifications.

• Responsible for the establishment, leadership and support of the entire Commercial Quality Department ensuring adherence to applicable laws, regulations, and standards and ensuring empowered leaders to drive a culture of quality within the PHL Facility.
• Set and communicate team goals, manage employee and Quality System performance through leadership, coaching and mentoring techniques.
• Coordinates objectives with production procedures in cooperation with other plant managers to maximize product reliability and minimize costs.
• Develops the quality teams in career and succession planning, rotational assignments and project work, and other tools and methods to broaden quality and business acumen.
• Drives and actively manages compliance and quality risks, communicates, and influences cross-functionally to ensure mitigation of prioritized actions.
• Directs workers engaged in inspection and testing activities to ensure continuous control over materials, facilities, and products.
• Plays active role on quality management teams within organization.
• This position may require overtime and/or weekend work.
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
• Attendance to work (onsite) is an essential function of this position. Performs other duties as assigned by Manager/Supervisor.

Quality Management System

• Formulates and maintains quality objectives complementary to corporate policies and goals.
• Develops Quality Systems that operate in harmonization with PCI’s other packaging locations.
• Develops Quality Systems in areas such as Validation, Inspection, Regulatory Compliance, CAPA, Documents, Change Control, Vendor Control, Investigations, and Metrics. 

Product and Process Control

• Creates and implements inspection criteria and procedures.
• Review of product risk hazards and management of a risk control program utilizing engineering controls, PPE, procedures, IH monitoring and all other applicable means of reducing handling risk of products.
• Provides inspection activity for product throughout production cycle. Applies Continuous Improvement tools and approaches to analytical and reporting processes within each department.
• Designs and implements quality training programs for key personnel in conjunction with managers.
• Reports on key quality measures for management and customers.
• Develops and analyzes statistical data and product specifications to determine present standards and establish proposed quality and reliability expectancy of finished product.

External Stakeholder Interface

• Hosts audits for customers as well as regulators and develops systemic corrective actions to any deviations noted.
• Key Customer Interface during select governance meetings, risk escalation, business development and associated activities.
• Works with customers and vendors to insure quality of all components for production.

Special Demands:

• Stationary Position: 3/4 of the day and up.
• Move, Traverse: From 1/4 to 1/2 of the day.
• Operate, activate, use, prepare, inspect, or place: From 1/2 to 3/4 of the day.
• Install, place, adjust, apply, measure, use, or signal: None.
• Ascend/Descend or Work Atop: None.
• Position self (to) or Move (about or to): From 1/4 to 1/2 of the day.
• Communicate or exchange information: 3/4 of the day and up.
• Detect, distinguish, or determine: From 1/4 to 1/2 of the day.

On an average day, the individual can expect to move and/or transport up to 10 pounds

less than 1/4 of the day.

This position may have the following special vision requirements.

• Close Vision ☐ Distance Vision ☐ Color Vision ☐ Peripheral Vision ☐ Depth Perception
• Ability to focus ☒ No Special Vision Requirements         

Work Environment:

• Work is primarily performed at a desk and/or in an