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:

Plans, directs, and coordinates Quality activities of a designated Customer Team to ensure that the goals and objectives of the team are accomplished within prescribed time frames and are 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. 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 a focused team to develop systemic corrective actions to any deviation notes.

• Oversee investigations, consumer complaints, CAPAs, DEA activities, NMR issues, etc. as needed.

• 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's Quarterly Business Review.

• Lead cross-functional Quality Improvement Projects that drive harmonization and improvement within the organization.

• Provide proactive quality assurance and risk assessment using FMEA, HCCAP, and Quality by design adherence to PCI and cGMP policies, procedures, rules, and regulations.

• Supply agreement adherence management.

• This position may require overtime and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules.

• Attendance to work is an essential function of this position.

• Performs and submits batch records, accountability reports, and necessary documentation to customers to facilitate product release.

• Performs finished product batch release of approved production lots.

• Performs other duties as assigned by Manager/Supervisor.

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 essential functions.

Required:

• Bachelor's Degree in a related field and/or 5-10 years related experience and/or training.

• College Level Mathematical Skills

• Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.

• Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.

• Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables.

Preferred:

• Ability to effectively present information to various people as the job requires.

• Ability to work independently and/or part of a team.

• Ability to show success in managing employees.

• Ability to set and achieve challenging goals.

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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.

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.

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