639 Granite Street, Suite LL25, Braintree, MA 02184
781.848.5500
781.848.5500
The Compliance Head is responsible for the overall compliance of the site’s systems of handling, manufacturing and distribution of biopharmaceutical drug substance.
Responsibilities:Makes sure that all aspects of the handling, manufacturing and distribution of biopharmaceutical products at the site comply with relevant cGMP regulatory and legislative requirements. Ensure that local quality systems and standard operating procedures are in place and that compliance with cGMP is maintained through training and audit. Manage the implementation of Corporate Policies to ensure quality processes are maintained and current. Manage critical complaints, recalls, counterfeits and product tampering. Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality related matters are provided to the whole site. Ensure that coordinated contact is maintained with the regulatory authorities and the local partners (suppliers, third parties, licensees, distributors). Directs and oversees investigations and studies. Ensure readiness for and plan, manage and lead Health Authority and partner inspections.
Requirements:Related experience should be in GMP-regulated industries. Must have a working knowledge of FDA and international regulatory requirements as well as industry quality management tools, standard, and quality systems. Must have an understanding of pharmaceutical industry trends and practices. Broad cGMP experience is required with knowledge and understanding of manufacturing, quality control, and validation requirements and activities.
QA Head will be responsible for Global Quality Management including all manufacturing sites, Third Party Suppliers and Development activities: Ensure that all aspects of the operational business comply with cGMP legal and regulatory requirements as well as corporate Quality Policies. Ensure that compliance and quality risks are understood and are always integral part of business decisions. Liaises with Development and Technical Operations to prospectively plan QA support for project milestones. Initiate all quality improvement and CAPA activities to assure timely successful completion. Support and supervise cGMP upgrade projects and ensure compliance with industry standards. Ensure site readiness for regulatory inspections. Ensure that sites QA are meeting global standards and principles with respect to organization, personnel qualification training, procedures, processes, performance and productivity. Evaluate performance reports of sites QA, initiate corrective actions where necessary, and perform follow-up on resulting measures and provides transparency. Support/supervise communications to regulatory authorities within areas of responsibility.
Requirements:Education: Graduate in Biochemistry, Chemistry, Pharmacy, Microbiology or another related science. Languages: English fluent in speaking and writing. Experience: Biotech QA Expert, 10+ years experience within the pharmaceutical industry, e.g. in Pharmaceutical Production and QA Operation. Profound GMP & GCP experience. Strong Leadership skills and experience in Matrix organization.
Responsibilities include running all aspects of Quality/Compliance for a full service, e-Clinical services firm: Develops and enhances quality processes to promote, facilitate and ensure compliance with all regulatory and company standards by: Evaluating, interpreting and applying FDA regulations and policies. Managing the writing, revising, reviewing and approving of all Standard Operating Procedures. Serving as site contact for communication with the FDA and other regulatory agencies. Providing training and guidance to staff regarding compliance and interpretation of regulations. Auditing systems and staff competency for overall facility compliance to FDA requirements.
Designs, develops, implements, leads and manages all quality assurance programs by: Managing site audits as requested by clients and/or regulatory agencies. Overseeing and enforcing quality initiatives and companywide compliance with regulatory requirements. Participating in the development and maintenance of all quality systems and process improvements. Leading and investigating quality issues and implementing corrective actions; identifying departmental strengths and weaknesses. Developing and implementing proper document management and change control processes. Providing regulatory guidance to management team.
Requirements:Bachelor’s degree in the life sciences or related field; advanced degree is preferred. 7+ years current experience in a Regulatory or Quality Assurance role within the pharmaceutical industry. 5+ years management experience in clinical development within the pharmaceutical industry. 5+ years experience in creating and maintaining SOPs. Expertise in developing and maintaining quality management systems related to software development in a regulatory environment. Expertise in Quality Assurance auditing and regulatory affairs. Must be familiar with US and EU regulations and guidance.
Experience in IT strategy development, cost management, organizational design, outsourcing, portfolio planning, infrastructure evaluation and planning, large-scale project management and IT aspects of M&A and divestitures.
Experience in commercial biopharmaceutical industry, U.S. government agencies or non-governmental organizations. Expertise in product development, portfolio management, supply, chain operations, manufacturing, quality and regulatory affairs, or public health preparedness. Experience with the Department of Health and Human Services, National Institutes of Health, Centers for Disease Control and Prevention, and Food and Drug Administration required. Candidates with Biologics and/or Vaccine industry experience are encouraged to apply.
Experience in supply chain operations, strategic sourcing, or transportation management is required. Experience in the industrial, aerospace, defense, electronics, and automotive industries is a plus, as it can be applied to both the public sector and the industries that serve government.
Candidates who have backgrounds in software and operations/supply chain experience in Electronic Equipment.
Health Care Services: Positions require consulting experience in health care delivery, or health care payer consulting preferably in government agencies, e.g., VA, or DoD or to non-government health care service companies.
A graduate degree is required, preferably in business, management, public health, or operations research. Experience in business development, strategy, new service development, or operations are strongly preferred. .
The Director of Manufacturing Technology will develop and manage a group of scientists, engineers and specialists at the site necessary to support a new growth strategy for the site. The Director’s primary responsibility will be to provide technical leadership in support of the fermentation and purification processes at the site. Responsible to partner with other functions both this site and other sites including manufacturing, quality, engineering, facility operations and project management teams to ensure timely and successful completion of key business growth initiatives and ongoing product release.
This individual is expected to provide leadership within Regulatory Affairs and will be responsible for actively contributing to the development and implementation of CMC regulatory strategy for small molecule products in development as well as coordinating all aspects of CMC regulatory submissions relevant to their assigned projects or programs. This person will serve as the regulatory CMC representative on relevant project teams, and as the regulatory CMC contact with FDA.
This individual is expected to provide leadership within the Regulatory Affairs Labeling and Promotional Compliance group and will be responsible for actively contributing to the development and implementation of regulatory labeling strategy and documentation for marketed products and products in development. This person will serve as the Regulatory Labeling representative on relevant project teams, and as a Regulatory contact with DDMAC for assigned products.
This position supports the Senior Director of International Regulatory Affairs as part of company’s Worldwide Regulatory Affairs Organization. Responsibilities for the Department include innovative international regulatory strategies for product development and approval (small molecule and biologics); facilitating preparation of international regulatory documents and various submissions, as well as any compliance matters; represent the company with international regulatory authorities, contractors and corporate partners; provide regulatory strategic direction to various departments, projects, and teams/committees. This position reports to the Senior Director, International Regulatory Affairs and is based in the US headquarters.
This individual will be an integral member of the Global Regulatory Dossier Management Group. This position will have overall responsibility for management of complex regulatory submissions, leading cross-functional submission teams for new drug applications (NDAs and MAAs) and investigational applications (INDs and CTAs). On a daily basis, this position will manage activities associated with generating regulatory submissions, including identifying and sourcing submission content, managing and planning submission timelines, managing the cross-functional submission review process and reviewing submission content for completeness and adherence to regulations and regulatory guidance.
This position is established to play a key role in the planning and management of regulatory submissions to global health authorities. This individual is expected to provide leadership within Regulatory Affairs and all other data-generating departments to ensure timely filing and approval of assigned oncology programs.
Management of assigned oncology programs; driving all submission activities (IND/CTA, trial maintenance, NDA/BLA) and health authority interactions (meeting requests and briefing documents)
To support the execution of the Global Audit schedule using knowledge of current regulatory requirements, internal standards, policies and procedures. Support site regulatory and key client inspections by providing technical expert consultancy in preparing and responding to potential compliance issues. Participate in site assessment by providing technical expert consultancy and regulatory knowledge to aid creation and support of site remediation activities. Where appropriate support the creation and execution of site compliance remediation plans through providing project management support on-site.
The Scientific Support Representative will answer inquiries from scientists to troubleshoot antibody-related applications, such as Western Blotting, flow cytometry, and ELISA. Additional responsibilities include working with product suppliers, participating in weekly Scientific Support Team meetings, providing updates and offering input on strategic decisions, and publishing customer feedback on website. Western Blotting experience is required.
Quality Assurance personnel will be responsible for record review for release of products and raw materials, reviewing and approving GMP controlled documents, internal auditing of quality systems, tracking and trending deviations, corrective actions, change controls, and investigations. Will also write documents, SOPs, and reports, perform batch record reviews, provide support for investigations of product failures, and be involved in generating Annual Product Reviews.
The Quality Control Associate – Microbiology is responsible for product testing, environmental monitoring, raw material testing, and general laboratory maintenance. Will perform in-process and final product sterility testing, air viable monitoring, particulate monitoring, purified water system testing, and surface sampling and growth promotion testing of raw materials. Must adhere to good documentation practices and ensure data traceability.
The Quality Control Manager will oversee the delivery of compliant laboratory data and will manage the Microbiology Laboratory operations on a daily basis and during FDA inspections. This role will oversee microbiological tests, monitor sample collection, testing, and data review, and will conduct and manage lab investigations, as well as working with Corporate Quality Control.
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Email recruiter Responsibilities:QC Bioassay personnel will be responsible for in-process, final product, and stability testing in Bioassay Laboratory (flow cytometry, ELISA, etc.) Manage key reagents, ensure laboratory data integrity and traceability, provide technical expertise during validation studies, responsible for data trending, assist with coordination of QC training, and participate in process improvement activities.
The Senior Quality Assurance Specialist will plan, coordinate, and conduct internal and external GLP and GCP related audits, including vendor audits, trial master file audits, system audits, investigator site audits, and study directed audits; collaborate with nonclinical and clinical research to ensure that research complies with SOPs, regulations and guidelines; participate in development of internal training programs.
Requirements:Qualified candidates will have experience in a GLP auditing role with bioanalytical lab auditing experience, working knowledge of 21 CFR Part 58, and must be able to handle multiple assignments and work independently and as part of a team.
Candidate will develop new RNAi based therapeutics, will perform synthesis and analytical characterization of novel oligonucleotides and oligonucleotide-conjugates supporting internal development and preclinical evaluations of lead compounds. Will interpret data and maintain detailed observation records. Candidate should have a PhD in Chemistry or related field and experience with analytical methods including HPLC, LC/MS, NMR, UV, and fluorescent spectroscopy, as well as experience with oligonucleotide synthesis.
Candidate will design, implement and oversee in vitro and in vivo experiments to assess efficacy and PK/PD of new siRNA conjugates in animal models. Manage a team of 3-5 PhD/MS biologists; select appropriate pharmacodynamic assays and tumor models for molecular target, interpret experimental data, present results at internal and national meetings, work with top managers to establish and meet company objectives. The ideal candidate will have a PhD or equivalent degree with expertise in RNAi target knockdown.
The Senior Quality Assurance Specialist will review and approve both master and executed batch records, take a lead role on interfacing with internal supply chain, quality control, and manufacturing personnel to resolve batch records. Also responsible for entering change controls, deviations and CAPAs in TrackWise, and batch record review data into Excel. The ideal candidate will have experience in drug product commercial manufacturing batch record review or experience in a GMP regulated environment.
The Senior Quality Assurance Auditor will review and approve master and executed batch records for API and final packaging and labeling; Will review quality control data ensuring results comply with specifications; will plan, coordinate, and conduct internal and external GMP audits, including internal system and process audits, vendor audits (raw material manufacturers, API manufacturers, GMP testing labs).
Requirements:Must have the ability to independently plan and conduct GMP related audits; have working knowledge of CFR and ICH Guidelines governing GMPs, will have experience in GMP Quality Assurance with experience in an auditing role.
Candidate will design a comprehensive GxP training program ensuring compliance within Quality Systems, Quality Assurance, and Quality Control. Training program will be for new and existing employees and will include developing curriculum for GxP functions; Will evaluate re-training needs based on performance analysis: track training metrics and report to senior management.
Requirements:Must have experience developing a training program in a pharmaceutical lab and/or quality systems department.
