Remediation Lead

As the Remediation Lead, you will provide senior Quality leadership for the design, integration, and execution of complex remediation programs at Round Lake Drug Delivery. You will translate regulatory observations, inspection findings, quality-system gaps, and internal commitments into practical, risk-based plans that deliver sustainable compliance, protect product quality, and support patient safety.

You will serve as the single point of integration across remediation workstreams, establishing disciplined governance, clarifying accountability, managing interdependencies, and providing transparent, fact-based reporting to site and enterprise leadership. You will partner closely with Quality, Manufacturing, Engineering, Laboratories, Supply Chain, Regulatory Affairs, IT, and other functions while preserving the technical accountability of process owners and subject-matter experts.

This role is ideal for an experienced Quality leader who combines deep pharmaceutical compliance knowledge with strong program leadership, sound regulatory judgment, and a demonstrated ability to drive complex work to evidence-based and sustainable closure.

What You’ll Be Doing

• Lead the development, integration, and execution of site remediation strategies arising from regulatory inspections, Warning Letters, OAI classifications, health-authority commitments, audits, quality-system assessments, and significant recurring quality signals.

• Translate commitments and identified gaps into clearly defined workstreams, accountable owners, milestones, dependencies, deliverables, interim controls, effectiveness measures, and objective closure evidence.

• Establish and maintain a risk-based remediation master plan and governance cadence that provides clear visibility to progress, overdue actions, critical-path constraints, resource needs, decision requirements, and emerging risks.

• Provide independent Quality oversight and constructive challenge to ensure remediation plans are technically sound, scientifically justified, regulatorily defensible, feasible, and aligned with commitments made to health authorities and internal governance bodies.

• Drive cross-functional execution across Quality, Manufacturing, Engineering, Maintenance, Facilities, Laboratories, Supply Chain, Regulatory Affairs, IT, Training, and Operational Excellence to remove barriers and maintain alignment.

• Strengthen investigations, root-cause analysis, CAPA design, change control, quality risk management, data integrity, and effectiveness verification to prevent recurrence and improve Quality System performance.

• Provide leadership and oversight for remediation involving sterile pharmaceutical manufacturing, aseptic processing, terminal sterilization, sterility assurance, contamination control, particulate and microbiological risk management, process validation, and equipment qualification.

• Coordinate the preparation and Quality review of regulatory responses, remediation status reports, inspection-readiness materials, leadership presentations, and supporting evidence packages.

• Ensure remediation records are complete, traceable, internally consistent, inspection-ready, and readily retrievable, with a clear linkage between identified gaps, corrective actions, implementation evidence, and effectiveness outcomes.

• Identify systemic themes, recurring failure modes, cross-workstream dependencies, and opportunities to simplify or standardize controls without weakening compliance requirements.

• Partner with functional leaders to assess resource and capability needs, sequence priorities, manage scope and change, and escalate decisions that could affect regulatory commitments, product quality, patient safety, or remediation outcomes.

• Create and monitor leading and lagging indicators such as milestone adherence, overdue-action aging, first-pass deliverable acceptance, CAPA effectiveness, recurrence, and evidence-readiness to verify that improvements are implemented and sustained.

• Coach workstream leads and subject-matter experts on clear problem definition, measurable deliverables, disciplined execution, evidence-based closure, and concise executive and regulatory communication.

• Serve as a trusted advisor to site and enterprise leadership, providing direct, objective assessments of progress, uncertainty, residual risk, and areas requiring intervention., “I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients’ safety.”

• Detail Oriented
• Continuous Learner
• Courageous
• Collaborative
• Critical Thinker
• Influential

Remediation Lead, * Bachelor’s degree in Pharmacy, Chemistry, Microbiology, Engineering, Life Sciences, Quality, or a related technical discipline.

• At least 8 years of progressively responsible experience in pharmaceutical, biotechnology, medical device, or another highly regulated manufacturing environment, including significant experience in Quality, Compliance, or Regulatory functions.

• Demonstrated leadership of complex, cross-functional remediation, compliance, Quality System, or transformation programs involving multiple workstreams and senior stakeholders.

• Experience supporting FDA or other global health-authority inspections, regulatory responses, and remediation associated with regulatory observations, Warning Letters, OAI classifications, Consent Decrees, or comparable enforcement actions.

• Strong knowledge of cGMPs, pharmaceutical Quality Systems, investigations, CAPA, change control, quality risk management, data integrity, validation, and inspection readiness.

• Experience in sterile pharmaceutical manufacturing, including aseptic processing, sterility assurance, contamination control, injectable products, IV solutions, and/or terminal sterilization.

• Ability to critically evaluate technical and procedural content, distinguish completed activity from demonstrated effectiveness, and identify weak assumptions, insufficient controls, or unsupported closure evidence.

• Proven ability to influence without direct authority, make sound risk-based decisions, manage ambiguity, and drive accountability and follow-through across functions.

• Excellent written and verbal communication skills, including the ability to translate complex technical information into clear, decision-oriented executive and regulatory updates.

• Strong program and portfolio management discipline, including management of scope, milestones, dependencies, risks, issues, decisions, resources, and change.

• Ability to work effectively in a 24/7 regulated manufacturing environment and provide support outside standard business hours when significant quality, inspection, or remediation needs arise.

• Ability to travel as needed to support regulatory inspections, remediation activities, and enterprise governance.

Preferred Qualifications

• Master’s degree in a scientific, engineering, quality, regulatory, or business discipline.

• Formal certification in project or program management, Lean Six Sigma, quality management, or change management.

• Experience leading remediation in a multi-building pharmaceutical operation or a complex sterile-manufacturing network.

• Experience with electronic Quality Management Systems, remediation portfolio dashboards, evidence repositories, and executive governance forums.

• Experience building organizational capability through coaching, leader standard work, structured problem solving, and disciplined performance management.

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

• Support for Parents
• Continuing Education/ Professional Development
• Employee Health & Well-Being Benefits
• Paid Time Off
• 2 Days a Year to Volunteer, We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $112,000 - $154,000 annually. The estimated salary is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

US Benefits at Baxter (except for Puerto Rico)

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching. We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter, Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

This is where your work makes a difference.

At Baxter, we believe every person-regardless of who they are or where they are from-deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.

Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.

Here, you will find more than just a job-you will find purpose and pride., Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.