Associate Director, Analytical Development and Quality Control Job at Kailera Therapeutics (Waltham)

Associate Director, Quality Control – Analytical Sciences

We are seeking an Associate Director to join the QC Analytical Sciences team in ...

Location

United States

Salary:

165000.00 - 185000.00 USD / Year

Apogee Therapeutics

Expiration Date

Until further notice

Requirements

Advanced degree in a relevant discipline (e.g., analytical chemistry, biochemistry, microbiology or related field)
7+ years of analytical development & quality control experience with complex biologics spanning early and late-stage development (GMP experience required)
Expertise/competence in several relevant analytical techniques such as HPLC, spectrophotometry, mass spec, ELISA, bioassay and microbiology
Strong understanding of global regulatory requirements (e.g., FDA, EMA, ICH) as they relate to analytical development, QC testing, and method validation
Hands-on experience supporting regulatory submissions (INDs, IMPDs, BLAs/NDAs, or equivalents), including preparation, review, and response to analytical sections
Excellent communication skills with an ability to collaborate effectively across functional lines
Ability to work independently and multi-task in a fast-moving organization
Availability to participate in calls across multiple international time zones
Successfully exhibit Apogee’s C.O.R.E. values: Caring, Original, Resilient and Egoless
Position requires up to 30% travel including mandatory in-person attendance at Apogee All Hands meetings typically held twice per year

Job Responsibility

Support the harmonization of QC analytical methods across internal laboratories, external vendors, and contract testing organizations
Partner with global and cross-functional teams to ensure successful implementation of harmonized methods
Support method transfers, validations, and comparability studies, ensuring adherence to regulatory and quality requirements
Provide technical oversight to vendors and contract laboratories, including troubleshooting and resolution of method-related issues
Author and review regulatory submissions (e.g., INDs, BLAs, MAAs) and support technical documentation, ensuring clarity, accuracy, and compliance with global guidelines
Generate and review technical documents, including protocols, reports, and method lifecycle documents

What we offer

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
Three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

Fulltime

Markets Data Analytics Risk & Control Lead, Director

This role is part of the Markets Data Risk team within Markets COO and focuses o...

Location

India , Pune

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

15+ years in data analytics within Markets (1st or 2nd line)
Strong grasp of financial products, operational intricacies, and various Markets Asset Classes (Equities, Rates, FX, Markets Treasury, Spread Products, Commodities, etc.)
Comprehensive understanding of how data influences business decisions, including expertise in data modeling and manipulation patterns
Knowledge of CDE and validation related data quality issues at process touchpoints in complex technology environments
Extensive experience in designing and monitoring key controls in Manager's Control Assessment (MCA), particularly within trading environments
Excellent oral and written communication skills
Proficiency with Excel, PowerPoint, Tableau
Robust analytical problem-solving abilities
Ability to understand the bigger picture while focusing on critical details
Skilled in interacting effectively at all organizational levels

Job Responsibility

Support the Head of Markets Data Risk and other Data Leads to drive execution of strategic deliverables aligned to Markets Data Plan
Collaborate with Citi leadership to define a target state data control operating model for Markets
Recruit and develop a data controls team
Comprehensively understand data quality issues to ensure resolution in the defined target state solutions with robust controls
Assess the effectiveness of existing data quality controls and recommend improvements
Participate in risk assessments and contribute to the development of risk mitigation strategies specifically related to data quality
Monitor and report on key data quality metrics and indicators
Liaise effectively with Internal Audit and regulators to articulate control implementation, data quality metrics, and associated remedial actions

What we offer

Chance to build an exceptional global network of professionals, trading desks, technology teams and 2nd line functions
Long-term career path across geographies and business lines
Competitive compensation package and benefits
Flexible work arrangements

Fulltime

Region Director Payer Analytics Economics-Mountain

As our Division Director, Payer Analytics & Economics, you will be accountable f...

Location

United States , Englewood

Salary:

66.26 - 98.56 USD / Hour

American Nursing Care

Expiration Date

Until further notice

Requirements

Bachelors Other Business Administration, Accounting, Finance, Healthcare or related field
Minimum of eight (8) years of experience in contributing to profitability through detailed financial analysis and efficient delivery of data management strategies supporting contract analysis, trend management, budgeting, forecasting, strategic planning, and healthcare operations
Minimum of three (3) years of healthcare or financial leadership experience
Managed Care and Healthcare experience strongly preferred

Job Responsibility

Manage the labor and operations of the Division Payer Analytics & Economics team(s) including the hiring, orienting, developing and managing of staff
Oversee quality control and quality assurance of Payer Analytics & Economics analytics deliverables and financial models to support the negotiation and implementation of appropriate reimbursement rates associated language, between physicians/hospitals and payers/networks for managed care contracting initiatives
Review and accurately interpret contract terms, including payer policies and procedures to appropriately contract performance and influence strategic pricing strategies
Monitor contract financial performance. Analyze and publish managed care performance statements and determine profitability
Provide training and oversight of the modeling of proposed/existing payer contracts negotiated by payer strategy and operations, including expected and actual revenues/volumes, past performance, proposed contract language and regulatory changes
Oversee and prepare complex service line reimbursement analyses and financial performance analyses. Develop methods and models (involving multiple variables and assumptions) to identify the implications/ramifications/results of a wide variety of new/revised strategies, approaches, provisions, parameters and rate structures aimed at establishing appropriate reimbursement levels. Prepare and effectively present results to senior leadership, and other key stakeholders, for review and decision making activities

What we offer

medical, prescription drug, dental, vision plans, life insurance, paid time off, tuition reimbursement, retirement plan benefit(s) including, but not limited to, 401(k), 403(b), and other defined benefits offerings

Fulltime

Associate Director Quality

This position is responsible for being Most Senior plant level Quality Managemen...

Location

United States , Saint Paul

Salary:

160000.00 - 220000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

In depth knowledge of the regulatory environment for manufacture of medical devices and therapeutics
Strong leadership skills and demonstrated success in managing a large team. Capable to manage in matrix and ability to interact successfully with multi-functions globally
Strong analytical, problem solving, and decision-making skills
Excellent verbal and written communication skills
Success working with multifunctional, global teams
Excellent interpersonal/communication/influencing/negotiation skills required
Extensive working knowledge of applicable quality and regulatory standards and regulations
Experience in risk management, validation, analytics and microbiology, within a GMP environment
Quality expertise on tech transfer
Comfortable and capable of gowning into an ISO 7/ISO 8 manufacturing environment

Job Responsibility

Acts as the Management Representative for Quality. Manages the Quality organization in a mid to large size plant. Builds up a strong performing Quality Organization with a clear vision and mission supporting growth and global expansion. Manages the batch review and release activities
Fulfills the role of PRRC, specific to: Ensuring conformity of the devices is appropriately checked, in accordance with the Quality Management System, before release
Ensuring Post-Market Surveillance (PMS) obligations are met
Ensuring reporting obligation relating to vigilance are met (referred to in Articles 87-91 of MDR)
Directs large programs and departments in support of division or company-wide initiatives. Is responsible for results in terms of product quality and conformance to regulations and Baxter policies
Develops and deploys the quality systems (e.g. management review, CAPA, design control, process control) that ensure products conform to defined requirements
Understands and deploys processes to assure conformance to regulations in a mid-to-large plant or a large program or department. Manage regulatory inspections
Periodically reviews the suitability and effectiveness of the quality system with executive management
Drives continuous improvement of processes and systems locally as well as deployment of such divisional and corporate initiatives with the objective of achieving quality, reliability and cost improvements
Assesses and advises senior management concerning acquisition targets

What we offer

Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
medical and dental coverage that start on day one
insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts

Fulltime

Senior Vice President - Underwriter - (Structured Credit and Real Estate Underwriting)

The Senior Vice President position will hold a critical role within the Structur...

Location

India , Mumbai

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

13+ years of credit, portfolio management or product experience (preferably real estate underwriting or asset management) in a financial institution, rating agency, financial guarantor, or asset management firm
Experience in leading a team and in coaching and mentoring junior bankers
Excellent organizational skills, prioritizing capabilities, attention to detail, and the ability to complete assignments within required deadlines in a fast-paced environment
Ability to understand capital markets products and complex financing and product structures
Ability to provide strategic insights and strong sensitivity to macro and regulatory issues, and impact of such issues on the various Risk families, including operational and franchise risks
Pro-active disposition with ability to work autonomously and within a team
Typically deals with complex and variable issues with substantial potential impact, where development of an approach/taking of an action involves weighing various alternatives and balancing potentially conflicting needs
Requires good analytical skills in order to filter, prioritize and validate potentially complex material from multiple sources
Knowledge of wholesale loan (syndicated / bilateral) product and business, including an understanding of legal loan documentation, loan / funding mechanics, deal structure, funds flows, etc.
On track for internal Senior Credit Officer designation is a plus

Job Responsibility

Accountability for ensuring strong analysis of the assigned Real estate portfolio ensuring consistencies with industry leading practices and compliance with all internal risk policies, standards and procedures
Interface with and support bankers in underwriting requests for commercial credit extensions for new and existing clients with ownership responsibilities for sound credit decisions and compliance with internal procedures/credit risk policy guidelines and standards
Adoption of leading practices in credit analysis, underwriting, and monitoring, including the end-to-end underwriting process, from early origination discussions to development of credit approval memos, and senior approval forums
Supervise analysts and associates to perform periodic monitoring of the portfolio
Ensure maintenance of organized credit files for credit, regulatory, and compliance purposes and ensuring compliance with WCR policies and processes
Perform quality control of the approval memos to ensure accuracy and completeness of input
Ensures team monitors the ongoing compliance of assigned deals with the documented financing terms and conditions, portfolio performance and financial triggers and makes appropriate recommendations with the aim of identifying and mitigating credit risks
Ensure ongoing and timely feedback and coaching of junior team to sustain a strong credit culture and an unwavering commitment to excellence in analysis and execution
Provide support to Director and other senior team members, lead projects and initiatives in the wider team
Support the ICM Real Estate Underwriting Verticals (Citi Community Capital, CRE) on strategic initiatives/projects

What we offer

Global Benefits
Best-in-class benefits
Work-life balance

Fulltime

Manager, Capital Project Controls

The Capital Project Controls Manager plays a critical role in Alterra Mountain C...

Location

United States , Denver

Salary:

127000.00 - 150000.00 USD / Year

Alterra Mountain Company

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Engineering, Construction Management, Project Management, or related field
Minimum 7-10 years of experience in project controls, project management, or construction management, with a focus on capital projects
Proven track record of achieving cost savings and efficiencies in capital project management, accounting and reporting
Strong knowledge of project risk management practices in design and construction processes
Experience in vendor management and contract negotiation
Excellent project management skills, with the ability to manage multiple projects simultaneously
Exceptional analytical and problem-solving abilities
Excellent communication and interpersonal skills
Proficiency in risk management software, enterprise resource management systems (D365 is a plus) and Microsoft Office Suite (Excel, Word, PowerPoint)
Broad knowledge of project management tools and industry specific software

Job Responsibility

Develop, implement, and manage project control plans to focusing on cost savings, forecasting accuracy, schedule monitoring, and risk/value engineering
Develop and implement strategic sourcing plans for real estate and construction projects to optimize procurement processes and achieve cost savings
Lead cost tracking, forecasting, and periodic schedule monitoring ensuring timely delivery of project critical path and delivery milestones
Identify and mitigate risks associated with capital projects
Ensure all projects meet quality standards and comply with company policies, industry standards, and legal requirements
Deliver regular reports on project progress, budget status, and risk management to senior management
Support the development and implementation of project control policies and procedures
Work closely with cross-functional teams, including project managers, operations, resorts, finance, legal, and external consultants to address project-related issues and ensure integrated delivery of capital projects
Establish and maintain relationships with key stakeholders including Project Directors, Development Operations Directors, Development Managers, Resort Project Leads, and Resort Leaders
Provide guidance, training, and review of work of lower-level professionals, fostering talent development within the team

What we offer

Free Ikon Pass for all eligible employees + additional free skiing/riding privileges across the family of Alterra Mountain Company resorts for eligible employees and their dependents
Discounted skiing/riding for friends and family of eligible employees across the family of Alterra Mountain Company resorts
Flexible Time Off (FTO) and Paid Time Off (PTO) policies for eligible employees to relax and recharge
Generous discounts on outdoor gear, apparel, rental cars, etc.
Medical, dental, vision, life, AD&D, short-term & long-term disability insurance, EAP, HSAs, FSAs, and more
401(k) plan with generous company match
Paid parental leave of up to 6 weeks for eligible employees
Commuter benefits (Denver employees only)
Hybrid workplace policy encouraging regular in-person collaboration in our dog-friendly company headquarters office located in Denver’s RiNo Art District neighborhood (for eligible employees)

Fulltime

In-Business QA, Business Risk Credit Analyst

The role involves quality assurance relating to Wholesale Credit Risk processes,...

Location

India , Mumbai

Salary:

Not provided

Citi

Expiration Date

Until further notice

Requirements

Relevant work experience in Risk & Control function focusing on Wholesale Credit Risk
Hands on experience of Data Science / Data Analytics
Deep understanding of control framework in the banks
Experience in BCBS 239 is highly desirable
Python is essential
Tableau and SQL are added advantages
Consistently demonstrates clear and concise written and verbal communication skills
Effective organizational influencing skills required
Excellent problem-solving skills
Ability to see the big picture with high attention to critical details

Job Responsibility

Support the In-Business Quality Assurance Head of Data Analytics to set the global strategy for and lead the implementation and ongoing delivery of a robust Data analytics and testing program for the Quality Assurance function as it relates to Wholesale Credit Risk (WCR) data governance
Provide effective challenge on the design and operation of the data and credit processes within ICM and report any identified gaps and concerns through quarterly reports published to ICM senior management
Ability to query and clean complex datasets from multiple sources to funnel into advanced statistical analysis
Hands-on experience in designing, planning, prototyping, productionizing, deploying, maintaining, and documenting reliable and scalable data science solution
Perform design and operational effectiveness assessments of various business processes within Wholesale Credit Risk
Participate and independently lead Quality Assurance Reviews (QAR) covering data-relevant aspects
Read policies, standards, and procedures to understand key pillars, responsibilities, associated risks, and expected controls for the business process(es) in scope
Lead data discovery to identify data lineage and controls for the defined business process in scope
Evaluate findings identified through the Quality Assurance process, determine materiality, and partner with business teams to drive sustainable remediation
Collaborate within IBQA teams and with QA Directors and provide them with analytics insights

Fulltime

Senior Audit Manager

Citibank, N.A. seeks a Senior Audit Manager for its Irving, Texas location. A te...

Location

United States , Irving

Salary:

213262.00 USD / Year

Citi

Expiration Date

Until further notice

Requirements

Requires a (3 or 4 year) Bachelor’s degree, or foreign equivalent, in Business Administration, Finance, Accounting, Commerce, or related field
8 years of experience as a Vice President, Associate Director, Group Leader – Analytics, Assistant Manager, or related position involving regulatory compliance audits in the global financial services industry
8 years of experience must include: Reviewing, validating and remediating audit and regulatory issues, validation strategies and completed tests
Preparing audit documents for submission to regulators
Serving as a liaison to regulators, including explaining internal audit procedures
Concurrently managing multiple audit processes and assurance activities, including reviewing internal controls, creating risk and control matrices, supervising design and operating effectiveness testing, reviewing quality of work papers, and reporting and presenting audit findings
Analyzing report findings and recommending interventions where needed
Proposing solutions to risk and control issues

Job Responsibility

Lead a team of internal audit professionals who drive the business monitoring and governance initiatives in support of risk and control
Develop and retain a highly diverse and effective team, and assign assurance activities to the right resources
Escalate issues timely to the appropriate audit owner or responsible Chief Auditor, and partner with them to develop approaches for addressing broader emerging issues
Timely engage with the corresponding management to ensure issues are deliberated upon in advance and recommend sustainable corrective actions for mitigating the risks and the controls in failures
Lead concurrently multiple assurance activities related to an issue, ensuring deliveries are achieved within the expected budget and timelines
Ensure production of audit reports that are complete, insightful, timely, error free and concise
Ensure timely delivery of comprehensive regulatory and internal audits and issue validations
Support and endorse the Quality Assurance functions of Internal Audit and resolve issues found by QA, and improve audit processes and coverage
Assess the quantitative and qualitative factors that constitute inherent and residual risks associated with business decisions and the design of controls in place and their operating effectiveness

What we offer

medical, dental & vision coverage
401(k)
life, accident, and disability insurance
wellness programs
paid time off packages, including planned time off (vacation), unplanned time off (sick leave), and paid holidays

Fulltime

Associate Director, Analytical Development and Quality Control

Kailera Therapeutics

Location:
United States , Waltham

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
January 15, 2026

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