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Senior
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…
Philadelphia, Pennsylvania, United States · On-site
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Scientific Program Administrator, Scientific Programs and Initiatives
Philadelphia, Pennsylvania, United States · On-site
Mid level$150K raised
Overview The AACR is seeking a candidate to support AACR’s mission and programs that are designed to drive the scientific agenda of the organization. Specifically, this position will support the Managing Director, Scient…
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Full-time
bachelor degree, professional certificate
Posted 44d ago
~40 hrs/week
Responsibilities
Lead the development and execution of quality strategies for onboarding new products, ensuring alignment with regulatory and validation requirements. Serve as the primary Quality representative on cross-functional NPI teams and manage client interactions during technical transfers.
Requirements
Requires a Bachelor's degree in science, engineering, or quality with at least 5 years of experience in a regulated industry, preferably medical devices or pharma. Must have expertise in GMP, regulatory standards (FDA, ISO, ICH), and experience leading teams or mentoring staff.
Full 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. 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, 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.
Related keywords
NPIcGMPFDAISOICHFMEACAPALean Six SigmaASQ CQEMedical DevicesCombination ProductsPharmaceuticalsContract ManufacturingProcess CharacterizationValidation ProtocolsPPQ
We are PCI Pharma Services. CDMO.
Today’s Drug Development & Manufacturing, Advanced Drug Delivery & Drug Device Combination Products, Clinical Trial Services, and Commercial Packaging Technology. Inspired by tomorrow.
We provide world-class solutions through intelligence, ingenuity and innovation, together, delivering life-changing therapies. Across 38 global sites and supported by more than 8,000 dedicated employees, we bring together leading technology and continued investment to deliver seamless solutions from development to commercialization, supporting our clients to improve the lives of patients worldwide.
Offices: 3001 Red Lion Rd, Philadelphia, PA 19114, US · 23 Commerce Dr, Bedford, New Hampshire 03110, US · 4545 Assembly Dr, Rockford, Illinois 61109, US · 6166 Nancy Ridge Dr, San Diego, California 92121, US · 977 Century Dr, Burlington, Ontario L7L 5J8, CA
Clinical Trial ManufacturingPackagingStorageand Global DistributionAnalytical Development and TestingCommercial PackagingQP ServicesFormulation Development and Drug ManufacturingSterile Fill-FinishLyophilization Manufacturing Services
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There are currently 4,357 open healthcare positions in Philadelphia, PA listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Philadelphia, PA?
Companies currently hiring include Temple Health – Temple University Health System, Jefferson Health Plans, Children's Hospital of Philadelphia Research Institute, CVS Health, Merakey, among others. Browse the listings above to see every active employer.
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