Email Alert for
ⓘ There was an unexpected error processing your request.
Please refresh the page and try again.
If the problem persists, please contact us with your issue.
You can always manage your preferences and update your interests to ensure you receive the most relevant opportunities.
Get ready to discover your next great opportunity.
Alkermes, Inc.
Waltham, MA, United States
POSITION SUMMARY: Provide onsite QA Support for the Phase I/II Oral Dosage Manufacturing and Analytical activities and any related CDMO activities performed externally. Responsible for ensuring development programs are operating in compliance with the EU/FDA regulatory requirements and in compliance with company standards. ESSENTIALS AREAS OF RES
Job Source: Alkermes, Inc.Mastech Inc.
Woburn, MA, United States
Mastech Digital is an IT Staffing and Digital Transformation Services company. Mastech Digital provides digital and mainstream technology staff as well as Digital Transformation Services for all American Corporations. We are currently seeking a Quality Product Specialist for our client in the Engineering domain. We value our professionals, pro
Job Source: Mastech Inc.OnPage Corporation
Waltham, MA, United States
Position Overview In this role, you will define the capabilities that support thousands of users that rely on OnPage to receive critical notification and help manage uptime for some of the biggest brand technologies in the world. You will work on deeply understanding and synthesizing customers’ needs into clear and actionable product requirements;
Job Source: OnPage CorporationSartorius
Marlborough, MA, United States
In the Quality Control Lead role, you will assume responsibility for managing the QC activities that are pivotal in ensuring the quality and compliance of our new emerging therapy services. This includes the new GMP Phase 1 clinical production facility in Marlborough MA with the focus on novel modalities including allogenic stem cell, cell and gene
Job Source: SartoriusSartorius AG
Marlborough, MA, United States
In the Quality Control Lead role, you will assume responsibility for managing the QC activities that are pivotal in ensuring the quality and compliance of our new emerging therapy services. This includes the new GMP Phase 1 clinical production facility in Marlborough MA with the focus on novel modalities including allogenic stem cell, cell and gene
Job Source: Sartorius AGHexaQuEST Global, Inc.
Boston, MA, United States
Primary Responsibilities Lead test strategy, balancing priorities such as test coverage, test quality, competing demands, and project schedule. Track, measure, and report on progress identifying, writing, and executing tests, and resolving defects. Identify systemic problems, inefficiencies, risks, and opportunities for improvement; work with works
Job Source: HexaQuEST Global, Inc.Sartorius AG
Marlborough, MA, United States
As the Quality Assurance Lead, you will assume responsibility for supporting activities that are pivotal in ensuring the quality and compliance of our new emerging therapy services. This includes the new GMP Phase 1 clinical production facility in Marlborough MA with the focus on novel modalities including allogenic stem cell, cell and gene therapy
Job Source: Sartorius AGThe Brixton Group
Boston, MA, United States
Job Responsibilities: Organize and lead enterorise-wide initiatives to ensure that data quality is maintained so that data can effectively support business processes. Oversee analysis and reporting in support of regulatory requirements. Identify and recommend analysis of data quality, governance, or integrity issues. Evaluate data quality metrics a
Job Source: The Brixton GroupWaltham, MA, United States
Job Description
POSITION SUMMARY:
Provide QA Support for the Oral Dosage Manufacturing and Analytical activities at the Waltham site and any related CDMO activities performed externally. Responsible for ensuring development programs are operating in compliance with the EU/FDA regulatory requirements and in compliance with company standards.
ESSENTIALS AREAS OF RESPONSIBILITY:
Serve as quality assurance support and SME for development drug substance and drug product & OSD manufacturing maintaining knowledge of industry standards and regulatory requirements to ensure all drug manufacturing storage and shipping activities are compliant.
Responsible for reviewing contractor documents i.e. batch records, deviations and change controls to ensure they comply with Alkermes requirements.
Responsible for batch disposition of drug substance & drug product. Accountable for the on-time disposition of in line with the agreed schedule
Act as the quality contact for CMO's maintaining oversight at those CMO's for quality related topics
Support testing laboratories (internal and external) in establishing quality systems and QA oversite for Phase III, PPQ through commercialization for biologics.
Partner with colleagues to develop and negotiate quality agreements.
Lead quality risk management activities both internal development programs and at the contract manufacturers organization and manage mitigation plans with the CMO.
Support all PPQ process and product related activities for drug substance e.g. process characterization, cleaning validation, process validation (including e.g. stability studies, hold time studies, review and approval of protocols).
Preparation and development and maintenance of key performance indicators for the development and external quality biologics program to align with the company's quality objectives. Analysis of quality statistics (Pareto Analysis) to drive improvements.
Provide quality direction and input at the change review board and assume QA oversight of change controls ensuring scope of the record is clear and implementation activities are robust and timely.
Ensure compliance of quality systems other applicable regulations/standards and internal procedures. Support implementing improvements at the CMO in deviation and changer control systems.
Provide the requisite quality support to the regulatory/CMC group in support of licensee applications
In conjunction with the supplier quality group ensure all quality agreements are aligned with the requirement expectation from the CMO and CTO organizations.
Keep up to date with FDA/EU regulatory trends and requirements impacting the development and commercialization of products and advise colleagues and external partners to ensure compliance for clinical commercialization.
Build strong effective working relations with CMO's from a quality and compliance prospective.
Proactively support regulatory inspections at the CMO sites that may impact compliance status or require regulatory notifications.
Provide quality leadership for change management and significant deviations at CMO sites
Provide Quality leadership for customer complaints as applicable.
QUALIFICATIONS:
Minimum Education & Experience Requirements:
BS in scientific discipline or equivalent.
10-15 years' experience in the pharmaceutical industry; preferably in biologics drug substance processing
Experience in development/CMO operations preferred
Ability to interact effectively with health authorities
Knowledge/Skills Needed:
Strong communication skills and an ability to influence key stakeholders
Demonstrated strong negotiation skills
Demonstrated ability to prioritize work to act and work independently
Has a strong broad GMP and technical know how to handle emerging issues
Excellent verbal and written skills
Excellent interpersonal skills
The position will require up to 20% percent travel within USA
Personal Attributes Needed:
Team Player committed to quality; motivated self-starter; detail and results oriented; Well organized, efficient worker with good communication skills; innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks.
Can get things done on the basis of influence.
Comfortable working in a fast-paced environment with multiple issues open simultaneously.
Customer service mindset
Identifies opportunities to improve and contributes to problem solving.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
#LI-RS1
#LI-Onsite
About Us
Alkermes plc is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders. Headquartered in Dublin, Ireland, Alkermes has a research and development center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
#J-18808-Ljbffr
Email Alert for Product Quality Lead jobs in Waltham, MA, United States
ⓘ There was an unexpected error processing your request.
Please refresh the page and try again.
If the problem persists, please contact us with your issue.
You can always manage your preferences and update your interests to ensure you receive the most relevant opportunities.
Get ready to discover your next great opportunity.