Sr. Quality Compliance Specialist II

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the SUMMARYThe 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 sites 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 RESPONSIBILITIESThe 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 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 QUALIFICATIONSEducation: Masters degree with 3-5 years of relevant work experience or Bachelors degree in a scientific Bachelors 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 experience in pharmaceutical manufacturing :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 in word excel and Microsoft 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 -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