Manager, Clinical Quality Assurance at Alkermes, Inc. in Waltham, MA

The Manager position is an integral part of the CQA team and provides oversight for and participates in, auditing services in support of Alkermes Clinical Programs by conducting clinical site, vendor qualification, internal systems and document audits to ensure compliance with cGCPs. The CQA Manager supports the department initiatives by leading CQA projects and assists with management of department resources.

This position must be able to quickly identify critical and high risk business and compliance issues and report immediately to CQA management and assist/lead investigations and/or corrections of such issues.

This position reports to the Associate Director of Clinical Quality Assurance.

Responsibilities

Schedule, conduct and/or supervise Good Clinical Practice (GCP) audit services by an external vendor/consultant and/or internal resources (auditors) which will support Clinical Development activities including but not limited to:
- Audits of clinical vendors, clinical sites and clinical documents that will be submitted to regulatory authorities
- Audits of clinical drug safety activities internally and externally/ vendors
- Internal and external clinical development and drug safety systems
- Work with contract auditors and CQA management to develop study specific audit plans
Review and assess internal and external audit reports to ensure they have met the audit plan and that recommendations and suggested Corrective Action Preventative Action Plans (CAPA) are adequate all to ensure compliance with Standard Operating Procedures (SOPs), Regulations, and Best Practices.
Oversee and/or Conduct other GCP related audits as indicated
Collaborate with the appropriate Clinical Development team in preparation and follow-up to clinical site audits to ensure resolution of audit findings.
Plan and conduct GLP, GCP clinical vendor audits
When indicated collaborate with Clinical Development in a lessons learned debrief to identify the need for continuous improvement and for potential changes to work practices.
Consult with Clinical Development and Drug Safety regarding perceived GCP related vendor performance issues and when indicated work with them to develop a corrective action plan.
Provide review of follow-up corrective action of contracted vendor services
When indicated perform or supervise remote vendor audits and provide follow-up as indicated
Maintain the tracking system for all GCP audit activity and provide periodic metrics
When requested provide GCP training for clinical investigator meetings
Assists management in the preparation and conduct of regulatory agency inspections

Qualifications

Bachelor in Nursing, Health Science, Related field, and 8 + yrs. auditing and/or compliance experience for relevant GCP or GVP related fields. With Advanced Degrees, less audit/compliance years will be considered.
Must have experience in GCP auditing: clinical report, clinical investigational site, clinical vendor and drug safety/PV vendor.
Must have a working knowledge of US and International Conference on Harmonization (ICH) GCP regulations and guidelines.
Must have good interpersonal skills and excellent oral and written communication skills.
Must have knowledge of clinical safety and clinical trial management systems (e.g., ARISg, TrialWorks, and IMPACT) as well as standard tracking databases (e.g., TrackWise, LIMS).
Ability to work with cross functional groups, and handle difficult people/situations under pressure.
Ability to deal with competing timelines.
Ability to work independently and as part of a team.
Ability to prioritize work and handle multiple assignments.

Alkermes has recently adopted a hybrid working environment to support and meet the needs of employees and this role will operate in a flexible environment with 60% of time in the office and 40% from home. This position is eligible for the hybrid workplace model, requiring work to be completed onsite at our Waltham, MA office at least 3 days per week. This role is not eligible for fully remote work.

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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.