Director/Senior Director of Product Quality
Company: Dicerna Pharmaceuticals Inc.
Posted on: May 14, 2022
In Novo Nordisk (Dicerna) we are a patient-centred life-science
company on a mission to ensure that people living with a chronic
disease can live a full life. Millions rely on us every day. -
We're inspired by life in all its forms and shapes, ups and downs,
opportunities and challenges. From our colleagues in the lab,
working to change lives through pioneering break-through
treatments, to our colleagues putting sustainability at the core of
our processes, this mission to improve lives is at the core of our
The Director of Product Quality will:
Ensure quality activities are carried out according to the
Provide Quality oversight of contract manufacturing operations for
clinical trial and commercial materials Assure appropriate
resources for batch record/QC review and material disposition
Determine dispositions of drug substance, drug substance
intermediates, drug product and packaged/labeled products according
to established standards for clinical trial and commercial
Partner with Qualified Persons (QP) to ensure release of clinical
trial materials in accordance with the Clinical Trial Applications
(CTAs) in the EU
Provides quality oversight of Dicerna's proprietary starting
materials used in Oligonucleotide manufacturing
Write/review/approve written standards, including Master Production
Records, Standard Operating Procedures, Specifications, Test
Methods, and Change Control Documentation.
Conduct Quality / Technical review of product quality-related
issues pertaining to test methods and results, equipment, cleaning,
sterility, process controls, validation activities, etc. Provide
oversight of Stability Program management via oversight of
activities conducted by Analytical and Technical Operations
Manage product technical investigations (deviations, out of trend,
out of specification) associated with manufactured lots
Establish strong interfaces with contract manufacturers to address
and resolve complex and routine activities while building client
relationship and continuous improvement
Provide in-depth technical advice to project teams regarding Phase
I-IV manufacturing, analytical and process development
Work closely with Quality Systems group to support inspection
readiness both internally and at key contract manufacturing
Present key issues related to product quality to Quality
Support submission of INDs NDAs and CTAs.
Be a self-starting problem solver who drives results through high
compliance and a positive work style.
The Director of Product Quality is responsible for managing
assigned projects from inception to successful completion, making
coordinated use of processes and systems to guide and encourage
assigned personnel to successfully perform assigned tasks.
Additional responsibility for execution and maintenance (data
entry, reporting, filing, archival) of assigned quality system. -
Acts as technical resource for Quality. The duties listed below are
illustrations of the various type of work that may be performed.
The omission of specific statements of duties does not exclude them
from the position if the work is similar, related or a logical
assignment to this class.
The responsibilities associated with the Director of Product
Quality role include but are not limited to:
Responsible for material disposition, validation, certificates of
analysis, stability assessments and QA oversight of technical
Coordinates and manages, in conjunction with the QMS manager, the
configuration, implementation of quality systems/technologies
(processes and toolsets).
Identifies enhancements to business process and system design and
suggests solutions for implementation. Interacts with department
subject matter experts to define and harmonize processes
Participates as QA representative on relevant operations and
Performs technical quality assessments and QA approval of deviation
and OOS investigations for clinical and commercial products
including investigations of product complaints as required
Ensuring that deviations from batch records, protocols, sample
analysis plans, methods, or SOPs are documented and properly
Participate and/or Conduct Risk Assessment and / or Failure Mode
and Effects Analysis activities for both Design and Process FMEA's
or similar investigational techniques such as 5 Whys or 6 M
Participate in Material Review Board meetings- recommend
disposition and corrective action
Helps define and implement as appropriate quality standards, SOPs,
specification, methods, systems, and metrics for clinical and
Support Quality Management Reviews and periodic and annual product
Ensuring implementation and documentation of the appropriate
corrective action to resolve any problems or issues.
Monitoring and authoring Quality Assurance standard operating
procedures (SOPs) as required.
Evaluating contract service providers to assure compliance to the
required regulations and project needs. This includes Quality
review of Vendor Quality Assurance Agreement contracts.
Providing GxP training and advice to staff.
Assisting with ensuring that all partner audit reports are
responded to and resolved in a timely manner.
BS/BA in science related field or equivalent experience with 15 +
years of related Quality Assurance experience.
7+ years of quality oversight experience in a Quality Assurance
Director and leadership related function.
Expert knowledge of FDA, EU, ICH, requirements for GXP.
Knowledge of regulatory requirements for computer system
The ability to think strategically and maintain an attention to
The ability to interpret and apply these regulations and
requirements to daily work.
Strong problem solving/analytical skills.
The ability to understand and verify scientific text and data.
Knowledge of Microsoft Office - applications and spreadsheet
programs such as Excel, Word, Power Point, and Microsoft
The ability to work independently with minimal supervision,
interact with staff (at all levels) in a fast-paced environment,
sometimes under pressure, remaining flexible, proactive,
resourceful, and efficient, with a high level of
Excellent written and verbal communication skills, strong
negotiation and decision-making skills, and attention to detail are
The ability to comprehend regulations and guidance documents and
apply critical thinking skills to evaluate requirements and
effectively communicate written and oral findings.
Strong organizational skills, with the ability to handle multiple
KNOWLEDGE AND SKILL REQUIREMENTS:
Strong Customer Satisfaction Focus
Anticipated Compensation: $180,000 - $220,000 -
Keywords: Dicerna Pharmaceuticals Inc., Boulder , Director/Senior Director of Product Quality, Executive , Boulder, Colorado
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