Associate Quality Account Manager I
PCI Pharma Services | |
United States, Pennsylvania, Philadelphia | |
3001 Red Lion Road (Show on map) | |
Oct 01, 2024 | |
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 of Objective: Responsible for ensuring quality products and processes by aligning the members of the customer focused team with the approved quality standards of the site. Plans, directs, and coordinates Quality activities of a designated Customer Focused Team to ensure that goals and objectives of the team are accomplished within prescribed time frames and within budget. Select, supervise, empower, coach, develop and retain a team of qualified individuals including: Associate Quality Account Manager(s) and Quality Coordinator(s) while partnering with the Business Unit Manager to ensure that we deliver a quality product, on time, every time. Drives project success through active leadership to provide PCI a competitive advantage in long-term quality customer management. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. Select, supervise, empower, coach, develop and retain a team of qualified individuals through effective employee development, performance management, succession planning and recognition. Ensure the appropriate team structure is in place by performing workload analysis to manage headcount and to ensure we deliver on customer and business commitments. Establish quality team and individual goals and objectives in alignment with Customer Focused Team goals and customer requirements. Ensure strong alignment and coordination with other business units and functional groups. Collaborate on best practices with other Quality Account Managers and leadership. Facilitate the daily quality team performance to ensure goals and objectives are met and to build a culture of safety, quality, performance, customer service and continuous improvement. Manage the training and development of the team including cross training initiatives and on-boarding of new employees to the team. Provide support for customer audits, visits and conference calls. Work with Customer Focused Team to develop systemic corrective actions to any deviations noted. Participate in and oversee the completion of investigations, consumer complaints, CAPAs, DEA activities, Non-conformances, etc. Collaborate with the other team members to manage the team performance metrics and customer scorecard. Collaborate with the appropriate Account Executive and Business Unit Manager to coordinate and facilitate the customer Quarterly Business Review's. Provide proactive quality assurance and risk assessment using FMEA, HCCAP, and Quality by Design in compliance with PCI and cGMP policies, procedures, rules, and regulations. Manage the development of Master Packaging Instructions (MPI) for every product introduced to the team as well as the associated updates for all new and existing MPIs Oversee the timely issuance and review of batch records in order to meet production schedules and product release commitments to customers Drive improvements into all metrics including a reduction in batch record errors (RFT over 99%) and no overdue CAPAs, Customer Complaints, and DNs Ability to foster an environment of continuous process improvement. 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 and the ability to inspire and lead a team is an essential function of this position Performs other duties as assigned by Manager/Supervisor. Special Demands: 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. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions
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.
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 following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.
The noise level in the work environment is typically, moderate. Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Required:
Preferred:
#LI-KH1 Join us and be part of building the bridge between life changing therapies and patients. Let's talk future Equal Employment Opportunity (EEO) Statement: At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture. |