Manager II, Quality – Compliance

Baxter•Cleveland, OH

20h•Onsite

About The Position

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. This is where your creativity addresses challenges! You are creative, thorough, and a heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. As a Manager, Quality Compliance, you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in. You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality. Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation. The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always. The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves, so does the way our team approaches work as it strives to create top-of-the-line products. We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable, ethical, and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when there's a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.

Requirements

Bachelor’s Degree in a relevant scientific discipline; advanced degree preferred.
Minimum of 7 years of experience in quality assurance, compliance, or quality systems management within the pharmaceutical industry, with progressively increasing levels of responsibility.
Minimum 5 years’ experience managing people.
In-depth knowledge of relevant regulatory requirements, including cGMP, ICH guidelines, and pharmacopoeia standards.
Proven track record of successfully managing and implementing quality systems initiatives, including process improvements and compliance remediation activities.
Experience with electronic document management systems and other quality management software tools is desirable.
Excellent written and verbal communication, presentation, and facilitation skills
Strong negotiation skills and significant experience in interacting with regulatory authorities
Risk identification and problem solving skills
Proven track record to lead, mentor, and develop others for future growth and development
Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
Must have basic English written and oral communication skills adequate to communicate with other team members.
Strong leadership, communication, and interpersonal skills, with the ability to effectively collaborate and influence stakeholders at all levels of the organization.

Nice To Haves

Preferred Certification in quality management (e.g., ASQ Certified Quality Manager, Six Sigma) is a plus.

Responsibilities

Responsible for preparing for and hosting all regulatory (FDA, MHRA and Health Canada) inspections and for coordinating responses.
Responsible for hosting all customer audits and responses.
Responsible for ensuring all responses to regulatory and customer inspections are completed by the due dates.
Participate in training development to increase overall plant compliance knowledge.
Maintain current regulatory knowledge and current trends for FDA and other regulatory agency inspections.
Develop, implement, and maintain quality systems policies, procedures, and processes to ensure compliance with regulatory requirements, including FDA, and other authorities.
Provide strategic leadership and oversight for the management of quality systems, including but not limited to document control, change control, deviation management, CAPA, training, and audits.
Design and deliver comprehensive compliance training programs for employees of all levels to promote awareness of compliance obligations and foster a culture of integrity and ethical conduct within the organization.
Understands and deploys processes to assure conformance to regulations in a mid to large size plant of a large program or department.
Manages regulatory inspections.
Conduct regular assessments to identify potential compliance vulnerabilities and develop strategies to mitigate risks effectively.
Monitor changes in laws, regulations, and industry trends to anticipate and address emerging compliance issues proactively.
Establish monitoring and auditing processes to evaluate the effectiveness of compliance controls and identify areas for improvement.
Lead and participate in internal and external audits, inspections, ensuring timely responses and resolution of any findings or observations.
Lead investigations into compliance incidents, allegations of misconduct, or violations of policies and regulations.
Implement corrective actions and remediation plans to address identified issues and prevent recurrence.
Collaborate cross-functionally with various departments, including Quality Assurance, Regulatory Affairs, Manufacturing, and R&D, to drive continuous improvement initiatives and ensure alignment with quality objectives.
Monitor key performance indicators (KPIs), data analytics and metrics to assess the effectiveness of quality systems and identify areas for improvement.
Stay abreast of regulatory developments, industry trends, and best practices related to quality systems, and proactively implement necessary changes to maintain compliance and enhance operational efficiency.
Prepare and submit regulatory reports and filings as required by regulatory authorities.
Maintain accurate and comprehensive documentation of compliance activities, including policies, procedures, training records, and audit findings.

Benefits

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), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
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
commuting benefits
Employee Discount Program
Employee Assistance Program (EAP)
childcare benefits