SUMMARY:

The candidate is an important part of the PCI Philadelphia Quality Leadership Team and is a partner to our business and customers. Overall scope includes having the experience to balance product and process quality requirements, with respect to the demands of a broad portfolio of PCI customers and customer products. The position is responsible for the Quality Operations function supporting device assembly and packaging activities at the Philadelphia site.

ESSENTIAL DUTIES AND RESPONSIBILITIES INCLUDE THE FOLLOWING (OTHER DUTIES MAY BE ASSIGNED):

• Develops, establishes and maintains quality assurance programs and systems, policies, processes, procedures and controls.
• Provides direction and oversight to ensure that the operational performance and quality of products conform to established standards and agency requirements to ensure customer and regulatory satisfaction.
• Engages directly with customers on quality related issues to ensure PCI is meeting regulatory and customer requirements.
• Provides leadership over the Quality Operations teams that are involved in batch record creation, batch record review, product release, deviation management, change controls, and customer interactions.
• Supports key customer-facing meetings and venues such as business reviews, audits, risk - escalations, business development, and like activities.
• Establishes and ensures the Quality Operations team achieves the appropriate levels of compliance and develops actions to ensure ongoing performance is achieved and maintained through metrics and other forms of KPI's.
• Provides Quality leadership within internal teams (Operations, Engineering, Business Unit) to drive organizational unit objectives and achieve company goals.
• Establishes and ensures policy throughout the commercial manufacturing enterprise for the adherence to FDA, EMA, ANVISA and all other government agencies in which business is conducted.
• Responsible for the product quality lifecycle of respective products within drug delivery (e.g. Change Control, Deviations, Complaints, CAPA.)
• Drives continual improvement within the quality teams and operation to foster a culture of quality that permeates all levels of the organization.
• Ensures compliance and regulatory readiness of the operation at all times.
• Assists in the preparation for and participation in external regulatory inspections and audits that occur at the Philadelphia site.

SUPERVISORY RESPONSIBILITIES:

• Leads a group of approximately 2-3 direct reports (10-15 indirect reports)

QUALIFICATIONS :

BA or BS degree and a minimum of 10 years of experience with a minimum of 5 years in medical device/combo products. Operational quality and manufacturing experience in a pharmaceutical or biotech environment a plus.me

KNOWLEDGE/SKILLS REQUIREMENTS:

• An advanced degree in science or business administration is a plus
• Prior leadership experience in managing Quality teams with product release responsibilities
• Experience in managing contract service providers or working in a contract manufacturing or contract packaging environment
• Must be able to develop and improve advanced concepts, techniques, and standards and new applications based on quality principles and theories.
• Must be able to develop solutions to problems of unusual complexity, which require a high degree of ingenuity, creativity and innovativeness. Challenges are frequently unique and solutions may serve as precedent for future decisions which effect the entire organization.
• Must be able to interpret, execute, and recommend modifications to company-wide policies to achieve corporate goals and objectives.
• Experience in Root Cause Analysis and technical investigation writing
• Must have effective communication skills and the ability to deal across several multi-national agencies and organizations.
• Communication skills are required in effectively communicating and partnering between internal and external parties.
• Establishes and communicates vision, focus, and direction to align organizational and individual action and achieve results. Creates a "learning" culture that enables individuals to reach their maximum potential and builds the capability of the organization. Effectively manages talent to strengthen PCI. Creates an exceptional working environment that motivates high performance. Communicates a clear vision and expectations that create energy, enthusiasm, and commitment from others.

COMPUTER SKILLS :

• Microsoft Office is a requirement. Prior experience in the usage of an eQMS system is a must.

PHYSICAL DEMANDS:

Walking, sitting, standing.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Must be physically capable of performing the above duties with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions.

The employee must occasionally lift and/or move up to 10 pounds.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

The noise level in the work environment is usually moderate.