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.
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