Product Quality Lead
POSITION SUMMARY:
Provide onsite Quality Assurance (QA) support for the establishment and operation of Phase I/II oral dosage manufacturing and analytical activities, as well as oversight of quality-related activities performed by contract service providers in support of onsite manufacturing. Ensure that all development programs performed onsite operate in compliance with EU and FDA regulatory requirements and align with internal company quality standards
ESSENTIALS AREAS OF RESPONSIBILITY:QA support for onsite 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 GMP documentation related to onsite GMP activities, such as:
- Analytical instrument and method qualifications
- Stability protocols and data
- Master and executed batch records
- Cleaning verification protocols
- Quality risk assessments
- SOPs and work instructions (related to all functional areas)
- Raw material/API release documentation
- Deviations and change controls
- Establish and perform GMP operational activities in support of Phase I/II manufacturing, including:
- Sampling and disposition of incoming raw materials and finished products.
- Implementation, authoring and execution of the Cleaning Verification Program (including Sampling).
- Sampling and monitoring of the USP Water System.
- Development and oversight of the Environmental Monitoring Program.
- Operational training programs, such as gowning, sampling, and GMP fundamentals.
- Creation and maintenance of operational SOPs and programs as required.
- Issuance of Control records
- Liaise with Analytical Development, Process Development, Site Operations/ Engineering Alkermes QPs, other QA teams, to resolve discrepancies.
- Provide support to Alkermes QPs related to batch disposition.
- Compile deviations, change controls, analytical data and batch production record reports to support batch disposition by Alkermes QPs.
- 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 support to the regulatory/CMC group in support of regulatory filings as required.
- Provide support for complaints as applicable.
- Support internal and external audits as required.
QUALIFICATIONS:
Minimum Education & Experience Requirements:
- BSc. 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
- Experience working with Controlled Substance (a plus).
- Ability to perform work in GMP gowning with occasion need to wear a PAPR.
- Excellent verbal and written skills
- Excellent interpersonal skills
- The position will require up to 15% 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.
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About Us
Why join Team Alkermes?
Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. A fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients. Alkermes has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for various neurological disorders, including narcolepsy.
Beyond our important mission of developing medicines to address unmet patient needs, we actively seek to foster a culture of diversity, inclusion and belonging throughout our business. We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background and perspective makes us stronger. We are proud to have been recognized as an employer of choice by many national organizations, including being certified as a Great Place to Work in the U.S. in 2024, honored as a Healthiest Employer in both Ohio and Massachusetts in 2023, a Best Place for Working Parents in 2023, and to have received the Bell Seal at the Platinum level for Workplace Mental Health by Mental Health America for three consecutive years (2021-2023).
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other characteristic protected by local, state or federal law. Alkermes also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Alkermes is an E-Verify employer.
