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.
Keywords: PCI NH Lyophilization Services of New England, Bedford , Director of QC, Executive , Bedford, Texas
Click
here to apply!
|