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:

The Quality Account Manager is 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:

• 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:

• Stationary Position: From 1/2 to 3/4 of the day.
• Move, Traverse: From 1/4 to 1/2 of the day.
• Operate, activate, use, prepare, inspect, or place: None
• Install, place, adjust, apply, measure, use, or signal: None.
• Ascend/Descend or Work Atop: None.
• Position self (to) or Move (about or to): Up to 1/4 of the day.
• Communicate or exchange information: 3/4 of the day and up.
• Detect, distinguish, or determine: 3/4 of the day and up.
• On an average day, the individual can expect to move and/or transport up to 10 pounds less than 1/4 of the day.

Qualifications:

Required:

• Bachelor's Degree in a related field and/or 7-10 years related experience and/or training.

• Basic Mathematical Skills
• Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
• High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.
• High Standard of Report Writing

Preferred:

• Ability to identify and resolve problems in a timely manner.
• Ability to display a willingness to make decisions.
• Ability to show success in managing employees.

Join us and be part of building the bridge between life changing therapies and patients.

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.