- The manufacture, packaging and release of investigational medicines drugs supporting all Ipsen clinical studies,
- The quality activities of an international portfolio of subcontractors, diverse and high-tech product portfolio As a Quality expert, you are involved:
- transversely and within international and multidisciplinary project teams, in collaboration with the Ipsen pharmaceutical development sites, industrial sites and clinical departments,
- in the definition of the Quality requirements applicable to the products according to the stage of development on site and with our partners, As Leader you contribute to a Corporate Excellence approach:
- Establish a climate of trust from the outset and on a daily basis by promoting exchanges,
- Support skills development and celebrate successes,
- Develop a culture of continuous improvement in the implementation of the strategy.Main responsibilities / job expectations In compliance with the applicable regulation and Good Manufacturing Practices:
- Manage from a Quality point of view on assigned projects, the production, documentation and review of formal stability batches, and batches of drug substance and investigational medicinal products intended for internal or subcontracted clinical trials to guarantee the conformity of the products with the appropriate reference documents,
- Approve the documents necessary for the manufacture and release of batches such as Product Specification Files, Master Batch Records, Supply Chain flow diagram, associated documents (instructions, forms, development protocol/report, etc.), formal stability batches and clinical batches for drug substance and drug product,
- Ensure the management of changes for assigned projects according to the procedures in place,
- Manage from a Quality point of view the release of assigned products intended for clinical GMP trials and non-clinical GLP trials,
- Handle Quality events (deviations, OOS, change control, complaints, CAPA ...), associated with development studies and products for non-clinical GLP and clinical trials i.e. conduct and / or evaluate investigations related to Quality events and ensure the implementation of corrective and preventive measures,
- Anticipate and alert on any Quality issue that may impact on the Quality of products, the availability of products for clinical trials or the progress of projects,
- Check that the transport conditions I.e. Temperature excursions, of products intended for clinical trials guarantee their proper conservation,
- Ensure that assigned complaints are handled in accordance with procedures and within the required timeframe,
- Inform in timely manner the escalation of any deviation or major or critical complaints to direct manager or the VP Quality Pharmaceutical Development,
- Support the Quality decisions by providing the necessary information and recommendations. Contribute to the preparation and conduct of QSEBs,
- Assist with mock recalls, contribute to batch recalls,
- Ensure the implementation and compliance with procedures and instructions related to activities in his/her area of responsibility.
- Manage Quality activities and relationships with CDMOs and service providers for assigned projects. Manage their upgrading on operational quality aspects (i.e COAs, analytical validations/transfers, process validations, master & executed batch records, label proofs, specifications, executed batch record review and batch disposition of Drug Substance, Drug Product and Finished Products (oral solid dosage forms, parenteral, radio labeled materials)Quality support for projects development
- As Quality representative in development projects CMC cross functional workstream, act as key partner & ensure Quality support in assigned projects with a high level of autonomy and expertise,
- Ensure definition and compliance of the quality requirements,
- Ensure the follow-up of the projects for which he/she is responsible with his/her manager and ensure alignment with Pharm dev Quality Department managers,
- Act Communicate appropriately within Pharm Dev team (e.g. clinical supply chain, analytical ...) and CMC project leaders.Quality system
- Contribute to identify quality processes and related documentation needs for his/her scope ensuring the appropriate interface within global Pharm Dev QMS,
- Ensure appropriate change management internally or externally (analytical and/or chemical): monitoring, follow-up, records in Quality system, impact evaluation on the drug substance and drug product teams,
- Monitor Quality performance of local organization: Quality metrics data collection, targets definition, best practices promotion, improvement initiatives support, and appropriate reporting to Global Pharm Dev Quality,
- Support the coordination of the local and Global Pharm Dev quality management review in conjunction with global Pharm dev Quality Management System,
- Develop & provide cGMP & GDP SOP training in interface within global Pharm Dev QMS to support particularly clinical supply chain teams.Management.
- Direct consultants on complex projects
- Act as a subject matter expert and company representative during partner due diligence activities and regulatory inspections
- Perform regulatory compliance of regulatory filings (IND, IMPD)
- Oversee generation and review of documents used in cGMP & GDP activities such as Quality Agreements,Audits
- Contribute to regulatory authority inspections, partner audits or Ipsen Corporate audits as quality experts.Knowledge, abilities & experienceEducation / Certifications:
- Bachelor's degree in Scientific discipline (Pharmacy, Chemistry, or Biological Sciences) required
- Bachelor's degree or equivalent work experience in scientific or health related field preferredExperience:
- At least 8 years' experience in a similar position in a multinational pharmaceutical company
- Strong quality orientation
- Working in a matrix organization and interfacing with lead/management team.
- Ability to work with high workload and time pressure.
- Strong negotiation skills
- Excellent Computer literacy skills
- Strong organizational abilities
- Demonstrated ability to balance between detail orientation and overview with a good business acumen
- Broad pharmaceutical business knowledge
- Proven experience and leadership within Quality operations of multi-national biopharmaceutical settings.
- Extensive understanding of GxP, Quality Systems and Pharmaceutical responsibilities with experience as a QA Lead or Representative.Languages:
- English.Key Technical Competencies Required
- Excellent communication skills
- Strong presentation skills
- Team-player
- Acts as a Business Partner
- Ethical behavior
- Sense of urgency
- Analytical, problem-solving, and high-level organizational and time management skills.
- In-depth knowledge of relevant bio-pharmaceutical legislation and QMS requirements including GxP standards, Pharmacovigilance regulations.
- Strong understanding of operational platforms and validated databases to execute GxP quality compliance.
- Demonstrated LQA capabilities including affiliate QMS set up, implementation and maintenance.
- Ability to thrive in cross-functional environment (matrix organization)
- Ability to influence, negotiate and project manage.
- Ability to Travel as needed for self-inspection and face to face quality meetings when applicable. The annual base salary range for this position is $112,500-$165,000. This job is eligible to participate in our short-term incentives program. At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more. The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills. IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
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Quality Assurance Senior Manager - Cambridge Springs, United States - Ipsen Biopharmaceuticals, Inc.
Description
Title:Quality Assurance Senior Manager
Company:Ipsen Bioscience, Inc.
Job Description:
Quality Assurance Senior Manager
Ipsen is a global biopharmaceutical group dedicated to improving lives and health outcomes through innovative medicines in Oncology, Neuroscience and Rare Disease. We are committed to discovering new treatments in areas with high unmet medical needs and improving the quality of life for patients.
Research and development are key elements of our strategy, reflecting our commitment to improving patients' lives and health outcomes. Bolstered by a culture of collaboration & excellence, Ipsen offers a unique proposition to 5,700+ employees committed to society.
The Pharmaceutical Development organization is located across 5 Sites (France, Ireland, UK, US and Canada).
Within the Global Pharmaceutical Development organization, located across 5 Sites (France, Ireland, UK, US and Canada) you actively contribute to the strategy of becoming a center of excellence in the development of toxins, small molecules and medical devices and strategical partner in the life cycle management of the established products.
Key actor of the Pharmaceutical Development Quality organization, you are in support of:
