- Tris Pharma (Monmouth Junction, NJ)
- …Monmouth Junction, New Jersey, Tris has an immediate opening for a SR. Manager or Manager , Quality Management Systems (QMS). Title commensurate with ... improvements, including CAPAs and CPIs, across departments as appropriateApplies quality risk management principles in design (and resolution) of key quality… more
- Twist BioScience (South San Francisco, CA)
- Sr. Project Manager and Scrum Master (Hybrid in South San Francisco, CA)At Twist Bioscience, we help our customers change the world for the better. Our DNA-based ... world safer, healthier, and more sustainable.We are seeking an experienced Senior Project Manager and Scrum Master to join our team. The ideal candidate will have… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance, GCP/Document Audits supports end-to-end audit activities ... its partners as applicable ensuring the execution of a risk -based audit program and effective CAPA management resulting from...in alignment with the Master Audit Schedule, using a risk -based approach to ensure the Audit Plans are aligned… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …methodologies are understood and utilized. Serve as the lead "relationship manager " to deliver best practices to the business partners.Leads supplier relationship ... and conditions for cost, quality, payment terms, timelines, and mitigates any risk ; while ensuring all contracts are executed in accordance with company… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) ... management of these. They will also be responsible for conducting proactive risk assessments related to regulatory processes on a consistent basis and identifying… more
- Novo Nordisk Inc. (Durham, NC)
- …development pathway) and with little to no guidance from the manager . Responsible for providing data-based insights as business and manufacturing intelligence ... to an end-consumer business decision-maker. Relationships Reports to Manager . Essential Functions Execute projects with the aim of developing, validating,… more
- Merck & Co. (Durham, NC)
- …projects to optimal execution strategies that carefully consider complexity, geography, risk and business impact.Find the best partners for the execution strategy ... input with a keen focus on clear and thorough terms, appropriate risk allocation and insurance coverage.Coach and assess teams' use of lean constructionManage… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM ( Risk Based Quality Monitoring) sets the vision and strategy for the RBQM function ... of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires...across different disease areas, and the ability to determine risk factors with and for other technical departments (eg,… more
- Merck & Co. (Durham, NC)
- …to meet performance objectives.Consults on an as-needed basis with next level manager on more complex decisions.Executes critical site review and review of ... cleaning validation documentation as needed.May act as a Quality Risk Assessment Lead.Education Minimum Requirement:-High School Diploma or equivalentRequired… more
- Merck & Co. (Rahway, NJ)
- …The successful candidate will be accountable for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering ... of Company policy. The Executive Director will be a manager of managers, with keen focus on coaching and...role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including… more
- Merck & Co. (Durham, NC)
- …our Manufacturing Division (Associate Director).-This role serves as a Virtual Plant Manager - responsible for leading a cross-functional team in oversight of our ... Meetings (with External Partner).-- Compliance:-Achieve compliance goals through a risk -based approach (Safety Regulations, Quality Assurance, Risk Management,… more
- Novo Nordisk Inc. (Durham, NC)
- …development pathway) and with little to no guidance from the manager . Responsible for providing data-based insights as business and manufacturing intelligence ... is not available at this time. Relationships Reports to Manager . Essential Functions Execute projects with the aim of...within compliance with a quality mindset that focuses on risk management & mitigation Support Corporate, PS AM, local… more
- Novo Nordisk Inc. (Durham, NC)
- …& stakeholders, management of vendor & service contracts. Relationships Reports to Manager or Senior Manager . Essential Functions Lead reliability program with ... of data entered to support reliability and maintenance excellence programs Lead Risk Management Planning workshops in anticipation of risks that could adversely… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Some responsibilities developing and implementing security controls and formulating operational risk mitigations. Relationships: Reports directly to the manager ... enterprise technologies and will also be responsible for performing technical risk and vulnerability assessments at the network, system, and application level.… more
- Aequor (Swiftwater, MN)
- …8 - 4:30PM EST Mon-Fri Hybrid (4 days onsite) JOB OVERVIEW: The Manager , Material Planning is responsible for the planning, coordinating, and ordering of materials ... to optimize availability and safety stock levels while minimizing risk of stock out, obsolescence, and expiration.Responsibilities: Manages their respective… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …candidate will be commensurate with experience. Relationships Reports to: Manager , Process Support (Downstream) Essential Functions Assist with coordinating ... Automation and GMPs requirements preferred Broad understanding of science and risk -based verification (IE ASTM E2500) Knowledge of good engineering practices… more
- Aequor (Waltham, MA)
- …to mitigate compliance risks identified. Other duties as assigned by manager . Skills 8&plus years of pharmaceutical manufacturing and/or Quality Assurance ... Ability to think critically, and demonstrated troubleshooting, problem-solving, and risk assessment skills Strategic thinking and high emotional intelligence Manage… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …West Lebanon, NH bioproduction facility. Relationships Reports to: Automation Manager Number of subordinates with direct/indirect referral: None Essential Functions ... with supervision and conduct testing Core roles include communication, compliance, risk management, and use of current technology System Design and Specification… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …documents where necessary with supervision. This position conducts regulatory risk assessment and recommends developmental options with supervision, and this ... Leads US FDA/EU EMA interactions with support from higher-level manager .Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory guidances. Serves… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …VP of Finance & Supply Chain. Reporting into this position are the Senior Manager - Financial Transactions; Director - Accounting & Fin Controls, and Director - US ... Sarbanes Oxley Sec 404 requirements Manage/reduce the Company's exposure to fraud risk and routinely evaluate business processes and external supplier oversight to… more
