Quality Manager, NPI

PCI Pharma Services; Pennsylvania; On-site; USD 120,000 - 150,000; Full time

Job summary

PCI Pharma Services in Pennsylvania is seeking a Quality Leader to guide quality strategies across NPI programs and new product onboarding. You will coordinate with cross-functional teams, manage critical QA deliverables, and ensure alignment with regulatory requirements to enable timely launches.

The role requires strong analytical and communication skills, expertise in CAPA and RCA, and experience with GMP/validation processes.

Qualifications

• Bachelor’s degree in science, engineering, quality or related field.
• Minimum 5 years in a regulated industry, preferably medical devices or combination products.
• Proven ability to manage client relationships and ensure timelines, quality deliverables, and compliance.
• Experience with packaging line optimization, process characterization and continuous improvement.
• Strong organizational, communication and problem-solving skills.
• Familiarity with equipment commissioning, qualification and validation processes.
• Expertise in technical writing, RCA and CAPA workflows.
• Knowledge of FDA/ISO/ICH regulations and manufacturing quality systems.
• Ability to lead teams, mentor staff and drive objectives.

Responsibilities

• Lead development and execution of quality strategies for onboarding new products.
• Serve as primary Quality representative on NPI cross-functional teams.
• Manage quality deliverables and timelines to support on-time launches.
• Act as primary Quality contact for client interactions and technical transfers.
• Make quality-related decisions including risk escalation and regulatory alignment.
• Prepare and review key project documentation (packaging specs, process flow, layouts, validation plans).
• Support equipment qualification and validation activities for commercial production.
• Participate in risk assessments (e.g., FMEA) to identify quality risks.
• Lead QA review of batch records and training in GMP standards.
• Define and report KPIs for NPI programs with internal and client teams.
• Write/review NPI deviations and change controls for compliance.
• Assist in regulatory inspections and client meetings.
• Ensure smooth transition from development/NPI to routine manufacturing.

Skills

Quality leadership

Regulatory compliance

Cross-functional collaboration

CAPA investigation

Data analysis

Education

Bachelor’s degree in science/engineering/quality

Tools

eQMS

ERP

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.

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.

• Lead the development and execution of quality strategies to support successful onboarding of new products, ensuring alignment with NPI program, validation and regulatory requirements.
• Serve as the primary Quality representative on cross-functional NPI teams, ensuring quality requirements are defined and integrated across all project phases (design transfer, process development, and validation).
• Manage quality deliverables and timelines in alignment with project milestones to support on-time, compliant product launches.
• Serve as the primary Quality contact for client interactions, including technical transfers, project meetings, and quality reviews across all NPI activities
• Make Quality decisions related to product quality, compliance, and regulatory requirements, including escalation of risks as needed
• Prepare and/or review and approve key project documentation including packaging component specifications, process flow diagrams, line layouts, validation protocols, and master packaging instructions.
• Support equipment qualification, packaging line readiness, and process validation activities to ensure operational readiness for commercial production.
• Participate in risk assessments (e.g., FMEA) to identify and mitigate potential quality risks.
• Provide Quality support for new equipment introduction, ensuring process capabilities are built in by design, and align UAT and FAT activities with Quality and regulatory expectations in collaboration with Validation, cross-functional teams, and equipment vendors.
• Lead Quality review of batch records and associated documentation and ensure appropriate GMP and product-specific training.
• Collaborate with internal teams and clients to define and report on key performance indicators (KPIs) for NPI programs.
• Write and/or review and approve NPI-related deviations and change controls to ensure compliance and proper documentation.
• Participate in client meetings, quality reviews, and support regulatory inspections.
• Ensure smooth transition from development/NPI into routine manufacturing, including support of PPQ, initial commercial campaigns, and launch readiness.
• Monitor early lifecycle performance and address quality risks, issues, and continuous improvement opportunities.
• Ensure all NPI activities comply with cGMP, regulatory requirements, and internal quality standards.
• Manage day to day activities of quality team members in relation to NPI projects
• Allocate resources effectively to meet project timelines and compliance requirements
• Drive continuous improvement efforts within quality systems and NPI processes.
• Performs other duties as assigned by Manager.

Supervisory Responsibilities:

This role has the potential to supervise up to five Quality team members, with both direct and matrix (dotted-line) supervisory responsibilities, in accordance with organizational policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; workforce planning; assigning and directing work; performance management; employee development; addressing concerns; and resolving issues

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 daily and for various lengths of time.

• Work is primarily performed at a desk and/or in an office environment. for 1/4 to 1/2 of the day.
• Work is performed in areas with moderate risk or discomfort that may require special safety precautions, such as wearing protective clothing or gear for up to 1/4 of the day.
• 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 science, Engineering, Quality, or a related field.
• Minimum of 5 years of experience in a regulated industry, preferably in medical devices or combination products and experience in contract manufacturing, ideally within the pharmaceutical sector.
• Proven ability to manage and maintain strong client relationships, ensuring alignment on project timelines, quality deliverables, and compliance expectations.
• Experience with packaging line optimization, process characterization, and continuous improvement.
• Strong organizational, communication, and problem-solving skills are essential to successfully manage competing priorities and support project milestones.
• Familiarity with equipment commissioning, qualification, and validation processes
• Demonstrated expertise in technical writing, root cause analysis (RCA), and problem-solving methodologies.
• Strong analytical skills with the ability to lead complex investigations and drive effective corrective and preventive actions (CAPAs).
• In-depth knowledge of regulatory compliance requirements (e.g., FDA, ISO, ICH) and manufacturing quality systems.
• Demonstrated ability to lead teams, mentor staff, and drive organizational goals.
• Experience with continuous improvement methodologies such as Lean and Six Sigma.
• Proficiency in ERP and electronic Quality Management Systems (eQMS).
• Skilled in Microsoft Office and technical software tools.
• Ability to create, interpret, and present scientific data using tables, charts, and graphs.

Preferred:

• Lean Six Sigma Certification, ASQ Certified Quality Engineer (CQE), or similar certifications are highly desirable.
• Possess excellent organizational, time management and multi-tasking skills to meet commitments and deadlines.
• Critical thinking skills along with a strong collaborative approach is required.
• Technical knowledge and experience around Test Method validation, Medical Devices, and Sterilization processes is preferred.

#LI-KH1

Join us and be part of building the bridge between life changing therapies and patients.

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.