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Product Quality Lead
Location:
Waltham, MA
Description:
POSITION SUMMARY: Provide onsite QA Support for the Phase I/II Oral Dosage Manufacturing and Analytical activities and any related CDMO activities performed externally. Responsible for ensuring development programs are operating in compliance with the EU/FDA regulatory requirements and in compliance with company standards. ESSENTIALS AREAS OF RESPONSIBILITY: Onsite QA support for Phase I/II oral dosage drug product manufacturing and analytical activities, maintaining knowledge of industry standards and regulatory requirements to ensure all drug product manufacturing, testing, storage and shipping activities are compliant. These activities may include: QA review and approval of; Analytical Instrument Qualifications; Analytical Method Qualifications: API and Drug Product Specifications; API and Drug Product Stability Data; Master batch production records; Analytical records; Executed batch production records; Cleaning Verification Protocols; Quality Risk Assessments; GMP SOPs; approval of raw materials/API's and release for use Liaise with Analytical Development, Process Development, Alkermes QPs, other QA teams, to resolve any discrepancies noted during analytical and batch record review. Review and approval of deviations and change controls Compile deviations, change controls, analytical data and batch production record reports to support batch disposition by Alkermes QPs. Provide support to Alkermes QPs related to batch disposition. Collate batch disposition metrics and KPIs to monitor batch disposition process performance. Provide QA support for GMP manufacturing, including line clearances and other on floor production support to ensure manufacturing operations are conducted according to appropriate cGMP behaviors and in compliance with SOPs, batch manufacturing records and other cGMP documentation as applicable. Identify continuous improvement opportunities to ensure batch disposition processes are efficient and remain in a constant state of compliance. Provide the requisite quality support to the regulatory/CMC group in support of regulatory filings. Provide support for complaints as applicable. Perform internal audits as required. QUALIFICATIONS: Minimum Education & Experience Requirements: BS in scientific discipline or equivalent. Minimum of 10 years' broad experience in the pharmaceutical industry; preferably in Oral Solid Dose with strong background in associated Analytical testing, manufacturing and Quality Assurance in support of pharmaceutical development operations. Ability to be main point of contact and interact effectively in relation to on-site cGMP audits by external auditors. Knowledge/Skills Needed: Strong communication skills and an ability to influence key stakeholders Thorough knowledge of FDA and EU cGMPs and pharmaceutical manufacturing and analytical requirements Experience in pharmaceutical product development Strong ability to troubleshoot and problem solve Experienced in use of Quality Management Systems such as Veeva, Trackwise Digital, Valgenesis, SAP. Demonstrated proficiency in use of risk assessment tools Demonstrated strong negotiation skills Demonstrated ability to prioritize work to act and work independently Has a strong broad GMP and technical know how to handle emerging issues Excellent verbal and written skills Excellent interpersonal skills The position will require up to 20% percent travel within USA Personal Attributes Needed: Team Player committed to quality; motivated self-starter; detail and results oriented; Well organized, efficient worker with good communication skills; innovative thinker and problem solver; flexible and can embrace change; can manage multiple duties and tasks. Can get things done on the basis of influence. Comfortable working in a fast-paced environment with multiple issues open simultaneously. Identifies opportunities to improve and contributes to problem solving. Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.#LI-RS1#LI-OnsitePDN-9c11b9f8-e66e-4646-8f06-a92480e9bb40
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Product Quality Lead is a Other Jobs Product Quality Lead Job at Alkermes located in Waltham MA. Find other listings like Product Quality Lead by searching Oodle for Other Jobs Product Quality Lead Jobs.
Product Quality Lead is a Other Jobs Product Quality Lead Job at Alkermes located in Waltham MA. Find other listings like Product Quality Lead by searching Oodle for Other Jobs Product Quality Lead Jobs.