Manager, Quality Accounts

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 Focused Team to ensure that goals and objectives of the team are accomplished within prescribed time frames and in 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 Customer Focused Team to develop systemic corrective actions to any deviations noted. 

• 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 Quarterly Business Review’s. 

• Lead cross-functional Quality Improvement Projects which 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, 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 finish 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 the 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:

• Experience working in a GMP-regulated pharmaceutical or medical device environment, with strong knowledge of quality systems, validation processes, and regulatory compliance (FDA, ISO).

The hiring rate for this position is $77,600-$87,300 plus eligibility for an 10% annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.

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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, Equity and Inclusion 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.