Sr. Quality Compliance Specialist II

Kindeva Drug Delivery; Missouri; On-site; USD 110,000 - 140,000; Full time

Job summary

Kindeva Drug Delivery seeks a Sr. Quality Compliance Specialist II to lead inspection readiness and ensure adherence to cGMPs, regulations, and internal procedures across the site.

You will collaborate with business owners to close gaps and prepare for regulatory and customer audits. The role requires advanced education with years of pharma quality experience, strong communication, and the ability to train staff on compliance policies and SOPs.

Qualifications

• Master’s degree with 3-5 years of relevant work experience or a scientific Bachelor’s degree with 5-7 years of relevant work experience or comparable background.
• Experience in pharmaceutical manufacturing preferred.
• Excellent written and verbal communication across levels and regulatory agencies.

Responsibilities

• Ensuring manufacturing operations and quality procedures comply with 21 CFR Part 210/211, 21 CFR 820, 21 CFR Part 4, Annex 1.
• Maintaining and tracking internal and regulatory commitments for accuracy and timeliness.
• Assist and support manufacturing staff in detecting and solving compliance issues in real time.
• Review, edit, and author SOPs, audit reports, and other technical documents.
• Develop and provide training on compliance policies, practices, and reporting systems.
• Lead site inspection readiness and support audit activities with customers and regulators.
• Participate in internal audits and drive closure of observations.
• Assist in process improvement and KPIs reporting to Management.

Skills

Quality compliance

Inspection readiness

Audit support

Regulatory knowledge

Analytical thinking

Education

Master's degree in science

Bachelor's degree in Science

Tools

Microsoft Office Suite

Job description

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

Role Summary

The Sr. Quality Compliance Specialist II position is recognized as an expert internally in the principles and application of quality assurance, compliance, and inspection readiness. This role offers a unique opportunity to contribute your expertise and play a critical role in ensuring safety, efficacy, purity, and quality of manufactured products through compliance with cGMPs, regulations, and established procedures. This position will lead the site’s inspection readiness efforts for both internal and external (regulatory and customer) audits and will collaborate with business owners to ensure compliance through periodic review of process, procedures, and policies.

Role Responsibilities

• Ensuring manufacturing operations and quality procedures for the area(s) are compliant to 21 CFR Part 210 and 211, 21 CFR 820, 21 CFR Part 4, Annex 1 requirements.
• Maintaining and tracking of internal and regulatory commitments to ensure accuracy and timeliness.
• Assists and supports the manufacturing staff in detecting and solving compliance errors in real time.
• Assists in reviewing, editing, and authoring of SOPs, audit reports, and other technical documents.
• Developing and providing employee training on compliance policies, practices, and reporting systems.
• Act as a trusted advisor to the site by providing guidance through collaborative review and working with the business owners to gain a better understanding of their needs and facilitate resolution of compliance issues in a timely manner.
• Lead site inspection readiness and support activities.
• Participate in customer audits and customer visits related to new business opportunities and act as a liaison between quality assurance and client management.
• Participate in internal audit activities and help drive the closure of any observations.
• Participate in process improvement and continuous improvement initiatives.
• Tracking, trending, and reporting of compliance key performance indicators to Management.

Education

Master’s degree with 3-5 years of relevant work experience, or Bachelor’s degree in a scientific Bachelor’s Degree in Science preferred (Microbiology, Biology, Biochemistry, Chemistry, Engineering, Pharmacy, or related discipline) with minimum 5-7 years of relevant work experience, or relevant comparable background.

BASIC QUALIFICATIONS

• Previous experience in pharmaceutical manufacturing preferred.

Communication

Excellent written and verbal communication skills with the ability to share vision, direction, and data with colleagues across all levels and in a wide range of different work groups including senior leadership and regulatory agencies. Proficient in word, excel, and Microsoft applications.

Success In Role

• Strong analytical and problem-solving abilities.
• Tactful, persuasive, and assertive human relations skills.
• Effective leader, capable of making decisions using experience along with site process and procedures.
• Robust interpersonal skills and the ability to handle multiple projects. In-depth knowledge of combination product regulations i.e., FDA, EU, MHRA, etc.
• Experience in audit support and the ability to manage an audit response team.
• Self-motivated and adaptable, with a willingness to learn and adapt to changing responsibilities and priorities.
• Demonstrated commitment to values-based leadership and achieving objectives in alignment with Kindeva Drug Delivery values and behaviors.

Notice for California Employees and Applicants

Equal Opportunity Employer

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.