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.

* *Applicant must have experience in Quality Assurance for this position to apply**

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

• 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.

This position may have the following special vision requirements.

• Close Vision ☒ Distance Vision ☒ Color Vision ☐ Peripheral Vision ☐ Depth Perception

• Ability to focus ☐ No 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.

• Work is primarily performed at a desk and/or in an office environment. for 3/4 of the day and up.

• Work near moving mechanical parts for up to 1/4 of the day.

• Choose an item. for Choose an item.

• Choose an item. for Choose an item.

• Choose an item. for Choose an item.

• Choose an item. for Choose an item.

• Choose an item. for Choose an item.

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:

• 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.

• Various Preferences.

#LI-KH1

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