Director of QC

Company: PCI NH Lyophilization Services of New England
Location: Bedford
Posted on: January 26, 2023

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 SUMMARY -
This position is responsible for the daily QC oversight of PCI NH laboratory functions. This includes all financial, operational and technical activities in delivering quality chemical, biopharmaceutical and microbiologic testing services to our customers. This position directs and oversees core activities such as method development, method transfer/validation and formulation/process development testing support. The role includes oversight of raw material, in process, release and stability testing of GMP products to support our clients, interacting with Clients concerning project specific QC issues, approving department cGMP documents, contributing to cGMP reports, and managing QC staff as necessary to achieve these tasks

JOB DUTIES -
--- Leading Quality Control oversight of all cGMP testing of raw materials, in process, product release, and stability testing, clean utility and environmental monitoring testing. Review and approve all QC related investigations (deviations, OOS/OOT, EM Investigations, etc.) both with internal and external laboratories
--- Attract, facilitate, and participate in contract development and maintains good relations and communications with clients as a primary technical interface
--- Interact with customers to identify opportunities to improve quality and establish feedback with manufacturing and development personnel
--- Interface with supplier and customer quality representatives concerning problems with quality control and assure that effective corrective action is implemented
--- Working with project teams to represent the Quality Control, conducting risk assessments and introducing best practices into the Quality Control processes across all PCI NH business units
--- Leading customer interaction on all QC related projects including method development, method transfer/validation and routing testing updates
--- Work with Formulation and Process Development teams to provide timely testing of development projects.
--- Work with Sr. Director of Quality to develop long term strategies for capital expansion and expansion of service offerings
--- Manage and develop professional and technical skills and performance of department members
--- Assure all QC functions and testing are being performed according to FDA, EMA, ICH and other international regulations, as deemed necessary
--- Supporting regulatory information requests from customers as it pertains to QC. Supporting Operations, Project Management Staff and Quality Assurance as needed
--- Drive technical troubleshooting, operational improvements, and efficiency improvements while working within cGMP and global regulatory compliance
--- Demonstrate substantial knowledge of subject matter, industry best practices and trends
--- Other tasks as assigned by management

EDUCATION -
BS in Chemistry, Biochemistry, Microbiology, Biology or related life sciences field. Advanced level degree preferred

PROFESSIONAL SKILLS-
--- Demonstrates excellent verbal, written, and interpersonal communication skills
--- Demonstrated ability to perform in a fast-paced environment
--- Highly developed leadership capabilities to motivate and inspire teams

EXPERIENCE -
--- 15+ years Pharmaceutical or Biotechnology industry experience
--- Prior experience in leading a commercial, aseptic drug product quality control team is highly preferred
--- 5+ years progressive QC management experience
--- Quality leadership experience working on cross-functional teams to harmonize operational, testing and compliance processes
--- Prior experience in a CMO or dealing with CMOs preferred

QUALITIES -
--- Independently motivated, detail oriented and good problem-solving ability.
--- Demonstrates a strong customer service orientation with effective follow through
--- Driven to excellence while encouraging others to engage in process improvement and innovation
--- A leader who inspires and motivates, through excellent listening skills and a willingness to mentor team members

PHYSICAL REQUIREMENTS & MENTAL DEMANDS -
--- Frequent sitting, reading, writing, and verbal communication.
--- Must be able to travel between multiple local production facilities.
--- Able to translate ideas to actual concepts and processes.
--- Proven ability to manage multiple projects (duties) simultaneously.
--- Able to work in a highly complex environment with competing demands and priorities

COMMUNICATIONS & CONTACTS -
--- Works closely with internal quality control/assurance teams
--- Interacts with all departmental staff and other departments at all levels
--- Must be comfortable presenting technical and complex issues clearly to all levels of management as well as client representatives

MANAGERIAL & SUPERVISORY RESPONSIBILITIES -
--- Management of 5+ direct reports across multiple sites with overall group greater than 40 people

TRAVEL - less than 10%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.

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