What are the responsibilities and job description for the Senior Compliance Manager position at Sequel Med Tech?
About Sequel
Sequel Med Tech is an emerging medical device company committed to revolutionizing patient care through innovative solutions. Our mission is to improve the lives of patients by developing cutting-edge medical technologies that address unmet needs in healthcare.
Job Overview
The Senior Compliance Manager will oversee all validation activities, ensuring compliance with regulatory guidelines and internal quality standards. This role will lead cross-functional teams to implement and maintain validation processes for equipment, systems, and software critical to the organization. The position involves strategic leadership, regulatory compliance, and active engagement in operational excellence.
Job Responsibilities and Essential Duties
- Develop and execute validation deliverables, including validation plans, validation specifications, validation protocols, summary reports, and Standard Operating Procedures (SOPs).
- Oversee and provide guidance on validation activities, ensuring compliance with FDA 21 CFR Part 11, GAMP 5, ISO standards, and other applicable regulations.
- Act as a subject matter expert, offering technical direction and support to validation engineers and cross-functional teams.
- Collaborate with cross-functional teams to ensure validation requirements align with project timelines and regulatory expectations.
- Conduct risk assessments, gap analyses, and remediation plans for validation projects.
- Ensure the lifecycle management of validated systems, including implementation, change control, periodic reviews, and decommissioning.
- Lead efforts to prepare for internal and external audits, addressing validation-related queries and findings.
- Proactively drive process improvements and implement best practices for validation activities.
- Mentor and train team members on validation processes and regulatory compliance requirements.
- Maintain awareness of evolving regulatory expectations and technological advancements to ensure validation processes remain current
- Manage resources, budgets, and timelines for validation projects.
Minimum Requirements
- Bachelor’s degree in Engineering, Life Sciences, or related field.
- 10 years of experience in validation within a regulated environment, with at least 5 years in a leadership role.
- Expertise in validation methodologies, lifecycle management, and regulatory compliance.
- Strong knowledge of GxP regulations.
- Strong leadership, problem-solving, and communication skills.
- Experience in managing large-scale validation projects across multi-site operations.
- Familiarity with emerging trends such as CSA and predictive compliance.
Preferred Skills and Competencies:
BS or Masters' degree in relevant area
Required Knowledge, Skills and Abilities
Sequel Med Tech provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
Environmental/Safety/Physical Work Conditions
- Ensures environmental consciousness and safe practices are exhibited in decisions.
- Use of computer and telephone equipment and other related office accessories/devices to complete assignments.
- May work extended hours during peak business cycles.
- Physical requirements such as lifting specific weights.
- Some travelling is expected.
