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:
The position is responsible for leading and directing the Quality Engineers for the Advanced Drug Delivery segment at the Rockford, IL site. The position is responsible for balancing client and product timeline commitments, ensuring the product is produced according to the established control plan, design and product specifications, and driving continual improvement to ensure ongoing standardization, simplification, and optimization of the product manufacturing-assembly and final packaging processes. This role will interact and collaborate with internal team members, customers, suppliers, and contract service providers.
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.
- Provides leadership over the Quality Engineering (QE) team that is involved in supporting design transfer, risk management, statistical analysis of data, deviations, complaints, change management, and quality improvement projects.
- Direct oversight over Quality Engineers responsible for Advanced Drug Delivery business segment
- Leads QE team to support New Product Introduction and tech transfer for product launches as well as supporting the sustaining commercialized products
- Accountable for overall management, reviewing, planning, and administering of resource allocation and workload planning for the Quality Engineering staff.
- Oversee and administer site risk management program aligned to ISO 14971
- Oversee and approve PCI investigations including consumer complaints, trend investigations, calibration OOS, and laboratory or environmental monitoring product impact investigations.
- Oversee and approve site supplier non-conformances and supplier-related quality metrics
- Oversee generation of documentation such as Measurement System Analysis (MSA), Control Plans, Process Flow Maps, Inspection plans and techniques, GR&R, test requirements, and Test Method Transfer/Validation.
- Technical evaluation of change controls including risk assessment/implementation of risk mitigation strategies.
- Apply scientific statistical analysis techniques to proactively identify trends, identify root causes, and implement actions to mitigate reoccurrence.
- Statistical assessment of data to drive improvements.
- Supports and maintains quality assurance programs and systems, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established standards and agency requirements to ensure customer and regulatory satisfaction.
- Participates as a member in various steering committees to guide and influence the company’s focus on new products, new customers, and strategic initiatives.
- Prepares reports to company management detailing the status of open projects that support the capacity, regulatory, and quality improvement requirements of the plant.
- Presentation of quality standards, process flows, inspection plans, and/or issues both internally to stakeholders and externally to clients with confidence and accuracy.
- Establishes and ensures the Quality Engineering team achieves the appropriate levels of compliance and develops actions to ensure ongoing performance is achieved and maintained through metrics and other forms of KPIs.
- Support the recruitment, coaching, and development of quality engineers to achieve excellence and efficiency when programs are scaled.
- Partners with internal teams (Business Unit, Quality, Operations, Engineering, Validation) to achieve company goals
SUPERVISORY RESPONSIBILITIES:
- Leads a group of up to 10 direct reports.
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:
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College or Trade Degree required (engineering degree or related scientific degree). Must have a minimum of 5+ years of experience in an FDA regulated industry with strong preference to medical device or combination products.
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Demonstrated proficiency with personal computers, business software (e.g., MS Office) and technical software (ERP and eQMS systems). Ability to create, use and interpret scientific tables, charts, and graphs.
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Advanced Computer Skills: Ability to perform the most complex computer tasks and operate various computer programs.
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Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
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Analytical ability to drive effective Root Cause Analysis (RCA) and critical thinking for complex problem solving.
Preferred:
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Possesses excellent organizational, time management and multi-tasking skills to meet commitments and deadlines.
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Prior experience in technical writing and utilizing root cause analysis tools is required.
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Critical thinking skills along with a strong collaborative approach is required.
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Lean Six Sigma or other formal process improvement skillsets are highly desirable.
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Technical knowledge and experience around Test Method validation, MSA, and Medical Devices processes are preferred.
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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.
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What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.
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