Sr. Quality Compliance Specialist II

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

The essential functions of the position may include but are not limited to: 

• 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. 

BASIC QUALIFICATIONS

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.

•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.

#LI-Onsite