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.

　　SUMMARY:

　　The candidate will need to balance the requirements for consistency from a quality perspective within PCI versus the demands of a broad portfolio of customers and customer products. The position is responsible for the Quality Operations functioning for 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 ensuring that performance and quality of products conform to established standards and agency requirements to ensure customer and regulatory satisfaction.

　　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.

　　Interacts with customers and regulatory agencies to ensure PCI is meeting regulatory and customer requirements.

　　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.

　　Ensures PCI generated shipper labels are generated in accordance with customer and regulatory expectations.

　　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.

　　Management over the Quality Business Unit teams

　　Management of Label Room personnel

　　Responsible for Deviation Management

　　Partners with internal teams (Business Unit, Operations, Engineering) to achieve company goals

　　SUPERVISORY RESPONSIBILITIES:

　　Lead a group of approximately 5 direct reports (20 to 25 indirect reports)QUALIFICATIONS :

　　BA or BS degree and a minimum of 5+ years of operational quality and manufacturing experience in a pharmaceutical or biotech environment.

　　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 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 to perform 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 the essential functions.

　　The noise level in the work environment is usually moderate.

　　Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)

　　Equal Employment Opportunity (EEO) Statement:

　　PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

　　Why work for PCI Pharma Services?

　　At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.

　　PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled