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Director/Senior Director of Product Quality

Company: Dicerna Pharmaceuticals Inc.
Location: Boulder
Posted on: May 14, 2022

Job Description:

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 every action.
The Director of Product Quality will:
Ensure quality activities are carried out according to the regulatory requirements.
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 material.
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 departments
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 organizations.
Present key issues related to product quality to Quality Management
Support submission of INDs NDAs and CTAs.
Be a self-starting problem solver who drives results through high compliance and a positive work style.
Key Responsibilities:
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 transfers
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 project teams.
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 authorized.
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 Fishbone analysis
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 commercial operations
Support Quality Management Reviews and periodic and annual product reviews
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.
Qualifications:
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 validation.
The ability to think strategically and maintain an attention to detail.
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 Project.
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 professionalism.
Excellent written and verbal communication skills, strong negotiation and decision-making skills, and attention to detail are equally important.
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 tasks.
KNOWLEDGE AND SKILL REQUIREMENTS:
Leadership
People Skills
Strong Customer Satisfaction Focus
Team-oriented
Communication
Results
Problem Solving
Mathematical Skills
Anticipated Compensation: $180,000 - $220,000 -

Keywords: Dicerna Pharmaceuticals Inc., Boulder , Director/Senior Director of Product Quality, Executive , Boulder, Colorado

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