Quality Account Manager

PCI TRGR Penn Pharmaceutical Services Ltd; Philadelphia (Philadelphia County); On-site; USD 110,000 - 160,000; Full time

Job summary

PCI Pharma Services in Philadelphia seeks a seasoned Quality Account Manager to lead a Customer Focused Team, drive strategic quality initiatives, and ensure compliant product releases. You will partner with the Business Unit Manager, manage budgets, and mentor associates to sustain a culture of safety, quality and continuous improvement.

The role requires 7–10 years of QA leadership, a strong grasp of cGMP and regulatory expectations, and proven ability to collaborate across functions in a

Qualifications

• Bachelor’s degree with 7–10 years QA/quality leadership experience.
• Lean Six Sigma Black Belt (preferred).
• Strong understanding of cGMP and regulatory inspections.
• Proven ability to develop and execute quality improvement plans.

Responsibilities

• Lead and develop a Customer Focused Team to meet quality objectives.
• Coordinate with Business Unit Manager to ensure timely, compliant product release.
• Drive continuous improvement and metric reduction of defects and CAPAs.
• Prepare for customer audits and regulatory inspections with robust documentation.

Skills

Team leadership

Budgeting

Quality management

Cross-functional collaboration

Regulatory compliance

Education

Bachelor’s degree

Lean Six Sigma Black Belt

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Microsoft Outlook

Microsoft Project

Job description

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.

Job Title: Quality Account Manager Department/Group: Quality Location: Philadelphia

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 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

QUALIFICATIONS

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.

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 situatis.

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

Equal Employment Opportunity 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.

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.

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