Associate Director Quality Control
Company: Albireo Pharma, Inc.
Location: Boston
Posted on: May 16, 2022
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Job Description:
Albireo Pharma is a rare disease company focused on the
development of novel bile acid modulators to treat rare pediatric
and adult liver diseases. Albireo's lead product, Bylvay TM
(odevixibat), was approved by the U.S. FDA as the first drug for
the treatment of pruritus in all types of progressive familial
intrahepatic cholestasis (PFIC), and it is also being developed to
treat other rare pediatric cholestatic liver diseases with Phase 3
trials in Alagille syndrome and biliary atresia, as well as an
Open-label Extension (OLE) study for PFIC. In Europe, Bylvay has
been approved for the treatment of PFIC and has been submitted for
pricing and reimbursement approval. The Company is progressing a
Phase 1 clinical trial for A3907 to advance development in adult
cholestatic liver disease, with IND-enabling studies moving ahead
with A2342 for viral and cholestatic liver disease. Albireo was
spun out from AstraZeneca in 2008 and is headquartered in Boston,
Massachusetts, with its key operating subsidiary in Gothenburg,
Sweden. The Boston Business Journal named Albireo one of the 2019
and 2020 Best Places to Work in Massachusetts. For more information
on Albireo, please visit www.albireopharma.com .
Position Summary: The Associate Director of Quality Control is
responsible for , operational leadership for both drug substance
and drug product. Lead efforts to meet company objectives through
manufacturing and development support, including product quality
testing, method validation, method transfer, reference standards,
and stability testing. The incumbent is responsible for ensuring
all company, regional, and global standards and regulations are
met, and that the department is developed and maintained to a
standard that ensures the quality of products and materials
produced by our contracted partners. Assist with all CMC Quality
activities in preparation of the Phases 1-3 and Commercialization
(Regulatory filing).
This role reports to the Director of Quality Operations and is
based in Boston, MA. Starting date is flexible.
What makes this role special:
Seek to have a profound impact on young children and their
families
Work on a portfolio of multiple potential therapies
Gain a rare diversity of commercial experience
Provide input into strategy, as well as manage execution of the
Quality Control function
Help shape the culture and future of an emerging biopharma with a
big vision
Collaborate with a small, collegial team of good people
Learn from leadership with deep experience and a history of
success
Be part of an early biopharma company in an excellent financial
position
Enjoy great work/life balance, including flex hours, ability to
work remotely in a hybrid model , generous holiday schedule and
business-casual work environment
Responsibilities (may vary): This description is not intended to
provide an all-inclusive listing of duties and responsibilities.
Duties may change at the discretion of management, and/or
management may request duties be performed that are not listed.
This job description is not a contract of employment and does not
change your status as an at-will employee.
Key Duties and Responsibilities:
Lead the Quality Control function, effectively inertacting and
collaborating with cross functional teams and managing assigned
staff effectively.
Lead efforts to ensure manufacturing and testing organizations
(CMOs and test labs) are operating in a manner that is consistent
with regulations and internal policies from a Quality Control
perspective.
Review, evaluate and approve executed Batch and control records for
API and drug product including test results, Certificates of
Analysis as applicable for conformace to specifications and
analytical requirements.
Provide Quality Control oversight of all in-process, raw material,
stability, reference standards and final product testing for
clinical and commercial product manufacturing.
Review and analysis of all non-complaince events during tesing and
production. Assessment of any trends and CAPAs and CAPA
effectiveness.
Tracking of API, DP batch record status and linage.
Management of Albireo's commercial product stability program
including oversight of DS and DP stability programs, review and
analysis of data, establish trends and generation of stability
reports.
Ensure contract service providers (i.e. CMOs, CTOs, etc) adhere to
strict data integrity regulatory policies and provide constant
oversight of CSP operations to confirm data is ALCOA (accurate,
legible, Contemporaneous, original, Attributable) and traceable to
the raw data source.
Manage the reference standard program to ensure adequate quanities
and timely supply of reference/working standards and markers
including qualifications and re-qualifications at each CMO and test
laboratories.
Coordinate efforts for method validation and transfer of methods
for commercial, clinical and development projects as applicable in
coordination with Albireo CMC/Analytical and CMO/CTOAnalytical/QC.
Support Analytical and CMOs to establish method suitability through
proper testing and documentation.
Review and approval all protocols and reports associated with
stability, method validation and method transfer.
Review and/or approval of test methods, relevant protocols and
reports, specifications and Certificates of Analysis, assessment of
temperature excursions
Manage, coordinate internal changes and at CSPs using Albireo's
Change Control procedures.
Assure that source data and information is maintained and
traceable. Maintain appropriate documentation to demonstrate the
review and acceptance of the test data.
Prepare Annual Product Review and Quality Management Review reports
based on review of internal data or as provided from CSP for
applicable products
Contribute, QC check and help organize reviewed manufacturing
information and data for inclusion in regulatory filings
(CTD/NDA/BLA or IND, etc.)
Assist with conducting and ensuring internal QC checks and reviews
of the data generated by the Contract Sites
Represent QC at internal and CSP project team meetings. Effectively
communicate and support team needs.
Qualifications:
B.S. or M.S. in Chemistry or related science degree required
(Additional experience may be substituted for the advance
degree)
Minimum (7) years of experience in QC and/or Analytical Quality
within the Pharmaceutical
Strong working knowledge of Analytical sciences with the
understanding of industry and regulatory expectations and
requirements for both clinical and commercial application with the
ability to leverage to provide management and direction supporting
the QC function and Albireo's objectives.
Ability to work with all levels of organization and external
contract service providers to ensure compliance with current
regulations.
Good understanding of product process and development, from
discovery to commercialization
Knowledgeable with phase-appropriate CGMP regulations and ICH or
other industry guidance.
Experience with the CMC and Regulatory Filing requirements
Small molecule experience
PI177502205
Keywords: Albireo Pharma, Inc., Boston , Associate Director Quality Control, Executive , Boston, Massachusetts
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