Quality Assurance Manager

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) 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
* Commitment to the batch record redesign project in order to standardize documentation.
* Ability to foster an environment of continuous process improvement.
* Adherence to the appropriate Supply agreement, Quality agreement, PCI policies, and applicable cGMP policies, procedures, rules and regulations.
* Attendance and the ability to inspire and lead a team are essential aspects of this job.
* Able to budget and understand the financial implications and impact of decisions made within the team.
* Other duties as assigned by Supervisor/Manager.

SUPERVISORY RESPONSIBILITIES:
Directly supervises up to 5-10 associates within the Customer Focused Team. Carries out supervisory
responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include
interviewing, hiring, and training employees; staffing, planning, assigning, and directing work; appraising
performance; rewarding and disciplining employees; addressing complaints and resolving problems.

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 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. Must be physically capable of performing the above duties with or without reasonable accommodation which may be made to enable individuals with disabilities to perform the essential functions. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, and some degree of visual acuity.

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 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 noise level in the work environment is usually 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.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION AND/OR EXPERIENCE:
* Bachelor's degree from a four-year college or university and seven to ten years related industry experience in increasingly more responsible positions.
* A history of project accomplishment and leadership excellence strongly desired.
* Lean, Six Sigma, or process improvement experience; Lean Six Sigma black belt preferred.
* Direct experience working with various domestic and foreign regulatory authorities and supporting inspections.
* Must have excellent computer skills including Microsoft Word, Excel, PowerPoint, Outlook, and Project, and a working knowledge of GMPs.
* Familiar with the technical requirements of the International Conference of Harmonization (ICH) especially ICH Q9, A Risk Based approach to Quality.
* Experience working in multiple areas of Quality, such as Incoming Quality Assurance (IQA), Quality operations, metrology, and validation.

LANGUAGE SKILLS:
Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to effectively present information to top management, customers, public groups, and/or boards of directors. Must have strong interpersonal and excellent communication skills.

MATHEMATICAL SKILLS:
Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

REASONING ABILITY:
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

COMPUTER SKILLS:
* Must have excellent computer skills including Microsoft Word, Excel, PowerPoint, Outlook, and Project

#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:
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.