Quality Assurance Manager
Job Location:
Job Location:
Waltham, MA - USA
Monthly Salary:
$ 139000 - 169000
Monthly Salary:
Posted on:
30+ days ago
Posted on:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Description
Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative purpose-driven culture we strive to create meaningful impact for patients.
Team Ardelyx is united by a shared mission and guided by our core values: Passionate Fearless Dedicated and Inclusive.
We foster an inclusive environment where employees are respected supported and empowered to make an impact both within our company and in the lives of patients we serve.
Team Ardelyx is united by a shared mission and guided by our core values: Passionate Fearless Dedicated and Inclusive.
We foster an inclusive environment where employees are respected supported and empowered to make an impact both within our company and in the lives of patients we serve.
Position Summary:
The Quality Assurance Manager will serve within Quality Assurance providing oversight and hands-on support for achieving QA milestones in a fast-paced pharmaceutical environment. This role will be deeply engaged in day-to-day quality operations including batch record review product disposition investigations quality agreements and quality systems support.
The position requires strong technical expertise in GMP quality systems CMC QA and quality risk management along with the ability to independently manage complex quality activities and partner cross-functionally across the addition to core operational responsibilities this individual will serve as the primary QA representative supporting operations on the East Coast and provide occasional back-up support to department management to help ensure continuity when coverage is needed.
Responsibilities:
- Serve as the primary QA representative supporting day-to-day activities for teams and operations located on the east coast
- Provide QA oversight for CMC activities supporting development clinical and commercial products
- Evaluate completed manufacturing documentation (batch records COAs packaging records and related GMP documentation) from CMOs to ensure accuracy completeness and compliance
- Review and approve batch record and product disposition activities in support of clinical trials process validation registration activities and commercial product distribution
- Review and approve development qualification and validation protocols and reports
- Collaborate cross-functionally with CMC Regulatory Affairs Supply Chain and external partners to support quality and compliance activities throughout the product lifecycle
- Provide QA oversight of CMO and suppliers activities to ensure required quality standards and regulatory expectations are maintained
- Generate Annual Product Quality Report quality metrics management review inputs and KPI reporting
- Ensure Quality Agreements clearly define GMP responsibilities and quality oversight expectations and responsibilities between parties
- Assist with inspection readiness activities and support internal and external GMP audits
- Participate in quality systems activities including deviations investigations OOS events change controls and related GMP processes
- Identify and support continuous improvement opportunities within QA processes and systems
- Ensure compliance with cGMP ICH FDA EU and other applicable regulatory requirements
This is a hybrid role (2-3 days in office) at our Waltham MA headquarters.
Qualifications:
- Bachelors degree in science or related field with 10 years of progressive GxP Quality Assurance experience within biotechnology or equivalent experience.
- Experience in relevant CMC area (DS DP) with an ability to introduce Quality-relevant (phase appropriate) best practices into the CMC development processes
- Experience in a manufacturing setting as a Quality person in the plant (QA PIP)
- Extensive knowledge of GMP regulations and guidance (such as FDA EU and ICH)
- Experience with Quality Assurance systems and processes
- Excellent investigational and QA problem-solving skills
- Strong technical writing skills
- Advanced software skills including SharePoint and Veeva
The anticipated annualized base pay range for this full-time position is $139000 - $169000 Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors including years of relevant experience training qualifications and internal equity. The compensation package may also include an annual bonus target and equity awards subject to eligibility and other requirements.
Ardelyx also offers a robust benefits package to employees including a 401(k) plan with generous employer match 12 weeks of paid parental leave up to 12 weeks of living organ and bone marrow leave equity incentive plans health plans (medical prescription drug dental and vision) life insurance and disability flexible time off annual Winter Holiday shut down and at least 11 paid holidays.
Ardelyx is an equal opportunity employer.
Required Experience:
Manager
About Company
From discovery through commercialisation, all of us at Ardelyx are driven to advance targeted therapies where significant medical needs persist.
