Sunovion Director Quality Control in Marlborough, Massachusetts
Sunovion Pharmaceuticals is looking for a Director, Quality Control to join our Quality Control Organization in Marlborough, MA.
The Director of Quality Control is responsible for ensuring data integrity compliance with the current Regulatory Guidance for all Quality Systems in Quality Operations, such as SunLIMS, Trackwise Digital, Solabs, and any other electronic system utilized in Quality for documentation management. Activities will be conducted in compliance with cGMP’s, Marketing Authorization Application, Investigational Drug Applications, and Sunovion Quality Systems.
The Director of Quality Control will be a champion for continuous improvement and will monitor industry requirements to ensure QC processes, such as real time data trending, reliable and efficient data extraction for periodic reporting, and assessment of the suitability of existing systems to perform intended functions, are adequate. The Director of Quality Control will work with Analytical Research and Development in the development and execution of method maintenance strategies for continuous improvement to address outdated software, equipment, and methodology.
This position will perform Quality Operations budgeting functions for preparations of necessary Statements of Work and Master Service Agreements, as well as approve invoices and monitor expenses to ensure budget is maintained within acceptable tolerances. This requires working in conjunction with Finance and Account Payable. This budgeting function will also include preparation of quarterly and yearly budget proposals, working with appropriate Sunovion financial partners for corresponding cost centers in coordination with Senior Director, Quality Control. The budgeting function will also include examining current testing strategies and evaluating/implementing cost savings measures by presenting cost reduction initiatives such as skip lot, reduced, matrix, or any other alternate or reduced testing criteria that meets industry and Regulatory standards. Position will also assist with analytical testing cost analysis, and work with Senior Director, Quality Control on identifying and implementing cost reduction measures.
The position will require management of quality control release, stability and product complaint testing performed by Sunovion’s contract testing laboratories on development and commercial pharmaceutical products and Active Pharmaceutical Ingredients (API). The Director position is responsible for all day to day and project related functions of the appropriate Quality Systems and routine Quality Control functions.
Works with system specialists to ensure systems are maintained in a compliant state in accordance with Data Integrity Guidance and interfaces with quality system owners to identify and solve and/or prevent compliance issues. Other Quality System responsibilities as follows:
Performs Data Integrity Gap Assessments of database functionality and procedures
-Ensures that processes required for the quality systems are established, implemented and maintained, and reports to Senior Director, Quality Control on the performance of these systems for their review and action, including recommendations for improvement.
Identify key Quality System Performance Metrics and Objectives and provide guidance to the organization on how to achieve the Objectives.
Direct projects to improve the quality systems for compliance, efficiency or changing requirements due to Regulatory changes or organizational growth needs.
Quality Systems within the scope of this role include, but are not limited to, SunLIMS, SOLABs, TWD, and oversight for inspection readiness (internal and vendor) of these systems and serve as the host/co-host of regulatory inspections for these systems
Perform a critical role in delivering Quality Systems that enables innovation, productivity, continuous improvement, adherence to applicable regulations and is focused on what’s most important – data integrity, product quality, reliability and patient safety.
Monitor the overall QC quality systems effectiveness – continuous improvements, trending, lessons learned/knowledge management, and striving for operational excellence.
Leads deployment activities for select external standards/regulations impacting QC Quality Systems.
Has oversite of QC Quality System procedures and validation activities for applicable updates or upgrades.
Works with system specialists to ensure systems are maintained in a compliant state in accordance with Data Integrity Guidance and interfaces with quality system owners to identify and solve and/or prevent compliance issues.
Coordinates upgrade/replacement when necessary
Oversees and coordinates resolution and documentation of software and hardware system issues .
Has oversight of the Quality Operations Annual Budget
Responsible for Quarterly Forecast and Annual Budget for commercial and developmental cost centers
Coordinates and drafts Statement of Work and Master Service Agreements for vendors
Reviews/Approves invoices and works with Accounts Payable for payment coordination
Responsible for organization and monitoring of routine invoicing, and escalation of issues to Quality Head when issues arise
Works with Analytical Research and Development on routine method maintenance to ensure review of methods and specifications to provide proactive resolution of issues and filing of appropriate submissions when equipment, technology, and software are becoming obsolete.
Provides oversight of Sunovion’s commercial and development drug product testing activities, including but not limited to the following:
Analytical testing, laboratory investigations, deviation management, protocol and report development and review.
Stability testing, reports, and investigations with global partners.
Supports Reference Standard Program
Leads complex QC investigations
Ensures cGMP testing of raw materials, API, container closure components, in-process materials and finished products.
Develops and administers the stability of preclinical, clinical and commercial drug substance and drug product.
Directs internal staff when appropriate and external contract laboratory staff where required.
Develops and maintains interdepartmental and external contractor relationships in a manner that effectively and efficiently assures GMP testing of commercial and clinical trial materials.
Monitors key performance indicators to manage and improve department performance. Interpret FDA and ICH guidance documents in order to implement the requirements/suggestions set forth in such documents. Provides over site for employee performance training & development to assure that personnel have the skills and capabilities to perform the duties assigned.
Develops and directs training for QC personnel as well as other Sunovion staff as needed.
Provides adequately trained staff to handle QC functions within a GMP framework
Mentors staff on regulatory and technical requirements
Directs CMC studies for development of pharmaceutical and biological drug substances and drug products.
Directs the development of appropriate specification controls from product development throughout post NDA approval for API’s, drug products, components and excipients.
Directs the preparation of analytical and stability CMC sections to NDAs and INDs.
Reviews other sections of regulatory submissions as required.
Prepare relevant sections of Annual Product Reviews.
Conduct statistical analysis using JMP or other statistical software tools.
Directs the development and maintenance of SOPs for QC and Stability.
Monitor departmental compliance with corporate and global quality standards as defined in the applicable Quality Manual.
Minimum Education, Experience, Knowledge and Skills Required
Minimum of Bachelor’s degree in chemistry or related scientific discipline.
Training in Data Integrity Requirements for Data Management Systems in Quality Role
Minimum of 10 years’ experience in pharmaceutical/biological drug product development, analytical chemistry and/or quality control in an FDA-regulated biotechnology, pharmaceutical or medical device company with progressive levels of responsibility are required.
Minimum of 5 years’ experience in management, with training and knowledge of Data Integrity Guidance and Data Management Systems utilized in a Quality Operation.
Minimum of 5 years in direct supervision of laboratory staff or project management. Experience in conducting analytical investigations on solid oral, aerosol, and sterile dosage forms.
The Director of Quality Control owns the process for deploying internal/external standards at Sunovion to keep us ahead of emerging regulatory expectations.
This includes oversight and continuous improvement of monitoring, assessment and implementation activities.
The Director will have experience with Quality Data Management systems, and be able to ensure compliance, along with coordination, management, and resolution of issues that arise.
Director will have strong technology aptitude, with hands on experience in electronic systems.
He or she will evaluate risk associated with analytical and product data and provide assessments to colleagues and senior management.
This person must be able to effectively interact with contract manufacturers and testing laboratories as well as an internal multidisciplinary team.
Internal staff or contractors will also be directed as necessary.
The Director will be expected to prioritize his or her own work and the activities of others based upon often rapidly changing situations.
The individual will critically evaluate and interpret FDA and ICH guidance documents and implement the requirements/suggestions set forth in such documents, with emphasis on Quality Data Management Systems .
The Director will be called upon to evaluate complex analytical data and make product disposition recommendations.
Stability and release testing data is interpreted in order to propose and approve specifications.
The Director will write, review and assess CMC sections of regulatory filings.
He or she will assure compliance to regulatory filings for such topics as stability, specifications and methods.
Must be a proven problem-solver, able to operate as both an individual contributor and a people manager to deliver on key objectives, flexing based on the business needs.
Experience managing direct reports.
Must be collaborative and outwardly focused.
He or she will be responsible for transition of product quality activities from a pre-approval status to that of commercial product status.
Confidential Data: All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Compliance :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sunovion are carried out with the "best" industry practices and the highest ethical standards.
Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Lead the way to a healthier world by putting patients at the center of everything we do
We are focused on developing innovative therapies and transforming the lives of people with serious medical conditions. We are creating innovative psychiatric, neurological and respiratory therapies that help transform people's lives, while at the same time we are playing an increasingly active role in the future of global health.
Sunovion Pharmaceuticals Inc. is an Equal Employment Opportunity (EEO) and Affirmative Action employer. Sunovion is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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