Provide technical design services for local and regional clients, lead a team of engineers and designers, and support instrumentation & controls engineering projects across the life cycle.
Locations (2)
Pune, Maharashtra, India
Vancouver, Washington, United States
Responsibilities
Provide technical design services for local and regional clients
Lead a team of engineers and designers
Support instrumentation & controls engineering projects
Implement efforts to improve product and engineering quality
Interface with clients to achieve program goals
Requirements
Bachelor’s Degree in related field or applicable discipline (Engineering degree preferred or equivalent experience)
Oversee overall operations of the clinical workflow in the sleep center, ensuring budget goals, performance improvement, quality measurement, staffing, hiring, compliance, training and protocol standardization.
Locations (2)
Galloway, Florida, United States
Miami, Florida, United States
Compensation
Estimated salary range for this position is $83400.24 - $108420.30 / year depending on experience.
Responsibilities
Execute and meet operational budget goals
Ensure continuous performance improvement and quality measurement
Evaluate and adjust staffing needs of clinical team
Assist in hiring appropriate personnel
Collaborate with operational leadership and ancillary departments
Lead and manage quality control for biologics programs, develop strategies, oversee testing, and guide regulatory activities.
Compensation
The salary range for this position is: $182,070.00 - $235,620.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
Responsibilities
Serve as the QC Lead and primary Quality Control point of contact for assigned biologics programs
Develop and maintain phase-appropriate, end-to-end QC strategies
Own or provide senior oversight of specifications and analytical methods
Provide QC oversight for testing performed at internal laboratories, CMOs/CDMOs, and contract testing laboratories
Provide scientific and quality guidance for deviations and regulatory content
Requirements
Ph.D. with 2+ years experience
M.S. with 8+ years experience
B.S. with 10+ years industrial experience
Nice to have: MS, MD, PharmD, or PhD
Nice to have: extensive progressive experience in biopharmaceutical or pharmaceutical Quality Control
Provide quality oversight for new product development and sustaining engineering projects, ensuring design controls, regulatory requirements, and quality standards are met.
Compensation
The estimated base salary for this position is $96,000 - $132,000 annually. This position may also be eligible for discretionary bonuses, commission, and/or long-term incentive.
Responsibilities
Provide quality support and oversight via direct staff supervision or process/area responsibilities
Identify and assess regulatory and quality risk in activities and processes
Provide quality assurance support for product design activities including design planning, input, output, review, verification, validation, transfer, and changes
Ensure compilation and maintenance of product Design History Files
Partner with Sustaining Engineering and R&D to ensure thorough design reviews
Requirements
Bachelor’s degree in engineering
Nice to have: professional certification in quality engineering
Lead the External Quality team overseeing quality oversight of Amneal's network of external manufacturers, ensuring compliance with cGMP and regulatory requirements.
Compensation
The salary range for this position ranges from $205,000 - $236,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award as well as a long-term incentive award, such as restricted stock units, with this position within the first 12 months.
Responsibilities
Lead quality oversight of 50+ external manufacturers, contract laboratories, and business partners
Establish risk-based oversight model and audit program
Serve as senior quality decisionmaker for external manufacturing issues
Represent External Quality in management review and Quality Council forums
Lead, coach, and develop a team of External Quality Managers and QA Leads
Requirements
Bachelor's Degree in Chemistry, Biology, Pharmacy, Engineering or other technical fields
Master's degree in Chemistry, Biology, Pharmacy, Engineering or other technical fields
Provide quality assurance support for pharmaceutical, medical device, and biologics manufacturing processes, ensuring compliance with regulations and internal standards.
Compensation
$ 65500 - 125500 USD
Responsibilities
Assist with proper integration and support of quality regulations
Assist project teams in planning, preparation, review and approval of quality documentation
Complete and route change requests for process document creation, maintenance, and implementation
Create quality system documentation and specifications
Assist with or co-lead audits of documentation, facilities and equipment
Requirements
Bachelor’s Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area
Nice to have: Knowledge of product, process, equipment, and facilities of pharmaceutical, biological or device related products
Nice to have: Knowledge of QA systems and GMP compliance requirements
Administrative and strategic leader responsible for the successful delivery of large, highly complex projects or multiple concurrent projects and teams. Role requires seasoned construction professionals with at least 15 years of experience.
Responsibilities
Build and sustain trusted relationships with clients and designers as a primary liaison and ambassador.
Represent Choate with credibility and professionalism in meetings, presentations, and industry engagements.
Lead safety from the front, ensuring project teams develop, maintain, and enforce Project Specific Safety Plans.
Partner with Division Leadership to negotiate contracts and resolve issues.
Guide clients through the preconstruction process, aligning stakeholders and shaping execution strategies.
Responsible for the delivery of a high-quality evidence-based laboratory service, reviewing and authorizing routine and specialist laboratory test results, offering advice on test selection, and providing high-level input into diagnostic testing approaches.
Responsibilities
Reviews and authorizes routine and specialist laboratory test results
Offers advice regarding appropriate test selection and test interpretation
Provides high-level input into diagnostic testing and approaches
Oversees assay development validation and implementation, and quality oversight
Participates in the senior management team of the Hematopathology division
Requirements
PhD degree
Relevant Board Certification, or Fellowship of relevant College
Serve, alongside the Technical Support Team Coordinator, as the primary leader for the Technical Support Team (~20 Technical Support Specialists, Senior Technical Support Specialists, and Junior System Administrators).
Act as the team’s first technical escalation point; help resolve difficult tickets, ensure the root cause is addressed, and escalate issues beyond the team’s scope to the Systems Administration Team or leadership with a clear problem statement.
Spend a significant part of each day on the floor: walking around, checking on work in progress, helping techs solve problems, and catching issues before they become client escalations.
Review tickets and resolutions regularly to ensure solutions are complete, documented, and aligned with S. J. Rollins standards; give specific feedback.
Identify recurring issues and process friction; drive fixes through documentation, training, or by routing them to the Systems Administration Team and leadership.
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