Associate Director Quality Job at Baxter (Saint Paul)

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

Associate Director, Quality Control Technical Services

Beam Therapeutics is a biotechnology company committed to establishing the leadi...

Location

United States , Cambridge

Salary:

185000.00 - 225000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Advanced degree (MS, Ph.D) in Chemistry, Biochemistry, Molecular Biology, or a related scientific discipline, with 8+ years of relevant industry experience in Quality Control, Analytical Development, or CMC within biologics, cell therapy, or gene therapy
Extensive hands-on experience with ex vivo autologous cell therapies, including CD34+ cell-based products, across late-stage development, validation, and/or commercial readiness
Demonstrated technical expertise in cell handling and testing methodologies, including functional and potency assays, flow cytometry, NGS-based assays, and separation sciences. Experience with analytical method automation, qualification, and validation is strongly preferred
Proven understanding of analytical method lifecycle management, including method transfer, qualification, validation, performance monitoring, remediation, and comparability, particularly for late-stage and commercial products
Strong working knowledge of US and EU regulatory expectations (e.g., FDA/CBER, EMA, ICH, USP) applicable to cell and gene therapy CMC, with the ability to apply guidance in a phase-appropriate and inspection-ready manner
Direct experience supporting regulatory submissions (INDs, BLAs, amendments, post-approval changes) for cell and gene therapy products, including specifications, method validation reports, and responses to health authority questions
Demonstrated ability to lead and influence cross-functional program teams, partnering effectively with CMC, Manufacturing, Analytical R&D, Quality Assurance, and Regulatory Affairs in a fast-paced, matrixed environment
Strong communication and leadership skills, with a track record of clearly articulating technical strategies, aligning stakeholders, and driving decisions across functions and with external partners
Documented success in driving complex, program-critical initiatives to completion on time and within budget, including managing dependencies, risks, and priorities across multiple workstreams
Highly developed organizational, analytical, and problem-solving skills, with the ability to interpret complex datasets, assess risk, and translate data into actionable QC and CMC strategies

Job Responsibility

Lead and influence QC CMC strategy in partnership with cross-functional CMC teams for master cell banks (MCBs), plasmids, and mRNA drug substance and critical materials, supporting both ex vivo and in vivo therapy programs across development and commercialization
Define and execute the QC testing, method strategy, and technical execution to enable next-generation autologous cell therapy manufacturing processes, including analytical readiness for process validation, comparability, and technology transfer
Own and coordinate analytical method transfer, qualification, and validation activities across internal and external QC laboratories, ensuring compliant, phase-appropriate, and inspection-ready execution
Establish and maintain analytical control strategies by tracking and trending in-process, release, and stability data, collaborating with statisticians and program teams to define and justify specifications for MCBs, plasmids, mRNA, and autologous cell therapy products
Define and oversee stability strategies and programs for MCBs, plasmids, mRNA, and ex vivo cell therapy products, ensuring alignment with regulatory expectations and lifecycle needs
Lead analytical method lifecycle management for late-stage and commercial ex vivo portfolio, including method performance monitoring, remediation, comparability activities, and continuous improvement
Drive the internalization of validated mRNA analytical methods into Beam's North Carolina Quality Control laboratory, strengthening internal capabilities and supporting long-term commercial supply
Author and review Quality System documentation, including SOPs, Change Controls, and CAPAs, to support method implementation, lifecycle changes, and inspection readiness
Partner with Regulatory Affairs-CMC to author, review, and coordinate CMC sections of regulatory submissions, including specifications, method validation reports, and responses to agency queries
Ensure QC visibility and alignment on regulatory interactions, including tracking agency questions, commitments, post-approval requirements, and method introduction or change strategies

Fulltime

Associate Director Quality Assurance

Responsible for providing oversight and leadership for Quality on-the-floor and ...

Location

Singapore , Singapore

Salary:

Not provided

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of directly related experience OR Master's degree and 6 years of directly related experience OR Bachelor's degree and/or 8 years of directly related experience AND Good understanding of IS system compliance with hands on experience of Computer System Validation or Compliance
10 years related work experience (manufacturing, process development, or quality assurance) in the pharmaceutical industry with progressively increasing responsibility and demonstrated experience in project management, quality assurance, and quality systems
Direct experience with bulk manufacturing of biopharmaceuticals preferred
Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff
Your selection for this role will be subject to fulfilling the medical requirements of this job scope

Job Responsibility

Ensuring Quality Assurance support for all ASM1 manufacturing activities (including on-the-floor quality oversight, batch record review, quality records approval)
Support routine GMP Oversight activities (e.g. SOPs, logbooks, reports) and ensure key performance indicators meet targeted metrics
Ensure required Quality resources are available to support commercial operations
Inspection Readiness and Support
Participate in root cause investigations for complex and significant exceptions or issues, leveraging various root cause analysis tools
Support site/network driven QA continuous improvement initiatives/activities
Escalate significant quality issues to Quality Management in a timely manner
Act as delegate to Quality Assurance Director when required to support business needs
Support Drug Substance Alignment Meetings for Functional areas
Providing guidance to the team

What we offer

Vast opportunities to learn and move up and across our global organization
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits

Fulltime

Associate Director, Quality Compliance

The Associate Director of Quality Compliance supports the site’s Quality Managem...

Location

United States , Round Lake

Salary:

152000.00 - 209000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in science or engineering required
advanced degree preferred
10+ years of experience in Quality Compliance/Quality Systems
3–5 years leadership
Recent pharmaceutical manufacturing experience is required
Strong knowledge of FDA/EMA regulations, QMS elements, and audit/inspection processes
Proven ability to lead audits, manage documentation systems, and drive compliance improvements

Job Responsibility

Lead day‑to‑day activities within the site’s Quality Compliance programs
Coordinate readiness assessments and preparation activities for regulatory inspections and corporate audits
Lead internal audits, supplier audits, and follow‑up activities
Assist in evaluating regulatory updates and enforcement trends
Oversee controlled documentation processes
Manage training system execution
Lead change control processes
Lead or support remediation teams focused on resolving compliance gaps
Work closely with QA Ops, Engineering, Manufacturing, Facilities, Supply Chain, and Regulatory Affairs
Manage and develop Quality Compliance staff

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

Associate Director, Quality Compliance

The Associate Director of Quality Compliance supports the site’s Quality Managem...

Location

United States , Round Lake

Salary:

152000.00 - 209000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in science or engineering required
advanced degree preferred
10+ years of experience in Quality Compliance/Quality Systems
3–5 years leadership
Recent pharmaceutical manufacturing experience is required
Strong knowledge of FDA/EMA regulations, QMS elements, and audit/inspection processes
Proven ability to lead audits, manage documentation systems, and drive compliance improvements

Job Responsibility

Lead day‑to‑day activities within the site’s Quality Compliance programs
Support implementation of sitewide compliance strategy, policies, and standardization initiatives
Coordinate readiness assessments and preparation activities for regulatory inspections and corporate audits
Serve as back‑room or front‑room support during inspections
Lead internal audits, supplier audits, and follow‑up activities
Assist in evaluating regulatory updates and enforcement trends
Oversee controlled documentation processes
Manage training system execution
Lead change control processes
Lead or support remediation teams focused on resolving compliance gaps

What we offer

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
Educational assistance programs
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave
Commuting benefits

Fulltime

Associate Director, Quality Compliance

The Associate Director of Quality Compliance supports the site’s Quality Managem...

Location

United States , Round Lake

Salary:

152000.00 - 209000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in science or engineering required
advanced degree preferred
10+ years of experience in Quality Compliance/Quality Systems
3–5 years leadership
Recent pharmaceutical manufacturing experience is required
Strong knowledge of FDA/EMA regulations, QMS elements, and audit/inspection processes
Proven ability to lead audits, manage documentation systems, and drive compliance improvements

Job Responsibility

Lead day‑to‑day activities within the site’s Quality Compliance programs
Support implementation of sitewide compliance strategy, policies, and standardization initiatives
Coordinate readiness assessments and preparation activities for regulatory inspections and corporate audits
Serve as back‑room or front‑room support during inspections
Lead internal audits, supplier audits, and follow‑up activities
Assist in evaluating regulatory updates and enforcement trends
Oversee controlled documentation processes
Manage training system execution
Lead change control processes
Lead or support remediation teams focused on resolving compliance gaps

What we offer

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
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service
Family and medical leaves of absence
Paid parental leave

Fulltime

Associate Director, Quality Compliance

The Associate Director of Quality Compliance supports the site’s Quality Managem...

Location

United States , Round Lake

Salary:

152000.00 - 209000.00 USD / Year

Baxter

Expiration Date

Until further notice

Requirements

Bachelor’s degree in science or engineering required
advanced degree preferred
10+ years of experience in Quality Compliance/Quality Systems
3–5 years leadership
Recent pharmaceutical manufacturing experience is required
Strong knowledge of FDA/EMA regulations, QMS elements, and audit/inspection processes
Proven ability to lead audits, manage documentation systems, and drive compliance improvements

Job Responsibility

Lead day‑to‑day activities within the site’s Quality Compliance programs
Support implementation of sitewide compliance strategy, policies, and standardization initiatives
Coordinate readiness assessments and preparation activities for regulatory inspections and corporate audits
Serve as back‑room or front‑room support during inspections
Lead internal audits, supplier audits, and follow‑up activities
Assist in evaluating regulatory updates and enforcement trends
Oversee controlled documentation processes
Manage training system execution
Lead change control processes
Lead or support remediation teams focused on resolving compliance gaps

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

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

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Associate Director Quality

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