GCP Quality Manager- Remote

  • Alector
  • Remote * (PO Box 60173, Philadelphia, PA 19102, USA)
  • Jan 15, 2022
Management Quality Assurance Telecommuting

Job Description

At Alector, our mission is to develop therapies that empower the immune system to cure neurodegeneration. Our team is solely focused on developing cures for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and board members, leading healthcare investors and some of the most innovative pharma companies.

Join us! We are seeking a highly motivated individual to join our team as GCP Quality Manager. The individual will work cross-functionally to support the development and implementation of clinical quality systems and processes to meet internatLetional Good Clinical Practice (GCP) requirements.

The Manager will lead initiatives to ensure robust performance of clinical contract service providers (CSPs); and in collaboration with Clinical Development groups, will deliver solutions to enable operations in accordance to ICH guidelines and local regulatory requirements. Responsibilities include establishing governance and performance metrics, reporting and identifying risks for remediation.

Outstanding soft skills and communication will be required to optimally establish and implement Quality Agreements with CSPs.

Requirements:
    • Bachelors degree in biological sciences or related field with a minimum of 8 years' experience in a pharmaceutical/biotech setting. Advanced degree is desirable.
    • Experience with Clinical Contract Service Provider operations
    • Proven, extensive knowledge of worldwide GCP regulatory requirements, industry practices, and application of concepts
    • Experience in developing and implementing quality systems and risk management tools
    • Familiarity with GMP, GVP, and GLP requirements
    • Ability to mentor, lead and develop teams collaboratively and constructively
    • Excellent interpersonal, verbal and written communication skills are essential in our collaborative work environment.
    • Demonstrate high organizational, prioritization and management proficiencies.
    • Ability to deliver in a fast-paced, small company environment and ability to seamlessly adjust workload based upon changing priorities.


Other responsibilities include:
    • Develop and implement performance metrics, analytics and reports for internal teams and external suppliers.
    • Clearly establish and manage audit plans and CAPAs for all CROs, laboratories, clinical sites, and internal Alector departments.
    • Support and enable inspections and inspection readiness activities for all internal and external entities
    • Parter with GXP Quality Team members to enable seamless execution of aligned Quality Systems at Alector


At Alector, we believe that high-performing teams include people from a wide variety of backgrounds and experiences who can challenge each other's assumptions with fresh perspectives and bring creative ideas to the table. We are committed to building an open, diverse, and inclusive environment for all employees. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, sexual orientation, age, marital status, veteran status, disability status, or any other characteristics protected under applicable federal, state, or local laws.

Alector is a great place to learn and experiment. If you excel in a dynamic environment where everyone is committed to finding a cure, where you'll drive growth, this is the role for you. There is no limit to how far you can go with us.

Benefits

While we've focused on what to look forward to during the first year and beyond, Day One is great, too: committed and driven colleagues, a bold and important company goal, state-of-the-art brand-new brightly-lit offices in the heart of the biotech area, competitive compensation and benefits. But these matter only if you're excited to build and own something great, and take on these challenges with us. Come join us.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.