Sr. Manager/Associate Director, Quality, (Validation and Data Integrity)

Larimar Therapeutics
RUNNEMEDE, NJ, US
Full-time
We are sorry. The job offer you are looking for is no longer available.

Description : The Company :

The Company :

Larimar Therapeutics Inc. is a publicly held clinical-stage biotechnology company focused on developing treatments for patients suffering from complex rare diseases using its novel cell penetrating peptide technology platform.

Our lead product candidate, Nomlabofusp (formerly referred to as CTI-1601), is a subcutaneously administered, recombinant fusion protein intended to deliver human frataxin (FXN), an essential protein to the mitochondria of patients with Friedreich's ataxia.

Friedreich's ataxia is a rare, progressive, and fatal disease in which patients are unable to produce sufficient FXN due to a genetic abnormality.

The company assembled an experienced management team, each of whom has over 20 years of pharmaceutical industry experience and has over 50 employees.

Their management team, employees, and consultants have significant expertise in discovery, nonclinical and clinical development, regulatory affairs, and the development of manufacturing processes utilizing good manufacturing practices.

The company's strategy is to become a leader in the treatment of rare diseases by leveraging their technology platform and applying their team's know-how to the development of nomlabofusp and other future pipeline projects.

We are best characterized by entrepreneurial and scientific leadership and a participatory workforce committed to success.

Position :

Sr. Manager / Associate Director, Quality, (Validation and Data Integrity)

Reports to : Senior Director, Quality

Position Summary :

The Sr. Manager / Associate Director, Quality, Validation and Data Integrity will be responsible to provide quality support and oversight for Larimar's validation activities and to manage the data integrity program, ensuring compliance with relevant regulatory requirements and industry standards / best practices.

This position reports to the Senior Director, Quality.

This role will require being in the office located in Bala Cynwyd, PA. At the current time, the number of days in the office is flexible and may change over time.

Job Responsibilities :

The responsibilities for the Sr. Manager / Associate Director, Quality, Validation and Data Integrity may include, but are not limited to the following activities :

  • Provide Quality oversight of Computer System Validation (CSV) / Computer Software Assurance (CSA) activities related to initial implementations, changes, periodic review, maintenance, and decommissioning of GxP systems.
  • Execute and manage risk assessment, planning, and execution / mitigation activities to ensure computerized systems used to support GxP operations are maintained in a qualified state throughout their lifecycles.
  • Author and / or review and approve relevant validation documentation, including but not limited to : URS, FRS, CS, DS, IOQ, PQ / UAT, VP, VSR, RA, TM.
  • Streamline and improve processes for GxP systems compliance in collaboration with IT and the business.
  • Participate in project teams to provide guidance and approval of project Validation documentation and relevant Change Controls.
  • Manage the data integrity program, including the timeline of activities for data integrity deliverables (e.g., data integrity assessments, CAPA actions, remediations etc.).
  • Deliver training on validation and data integrity principles / requirements to foster employee awareness and accountability.
  • Create and / or revise SOPs and Work Instructions supporting validation and data integrity activities.
  • Participate in vendor audits / assessments and qualification activities or internal audits involving GxP computerized systems as a Subject Matter Expert (SME).
  • Support GxP health authority inspections by serving as SME for computerized system and data integrity topics.
  • Support other Quality activities, as required.

Requirements :

Title and compensation will be dependent on years of experience and qualifications. This role requires a Bachelor's degree in a scientific or technical discipline and a minimum 6 years of experience in a Quality role in the biotechnology / pharmaceutical industry with at least 2 years' experience with computer systems validation.

Experience with GxP validation methodology is required. Strong understanding of 21 CFR Part 11, EU Annex 11 regulations, GAMP 5 concepts, applications and best practices is required.

The successful candidate will possess a strong attention to detail while having the ability to set priorities and meet aggressive timelines.

Benefits :

Larimar Therapeutics offers all employees incentive stock options, a comprehensive benefits plan including 401K, and a flexible PTO policy.

We are committed to equal-employment principles, and we recognize the value of committed employees who feel they are being treated in an equitable and professional manner.

We strive to find ways to attract, develop and retain the talent needed to meet business objectives, and to recruit and employ highly qualified individuals representing the diverse communities in which we live.

Employment policies and decisions on employment and promotion are based on merit, qualifications, performance, and business needs.

The decisions and criteria governing the relationship with all candidates and employees are made in a non-discriminatory mannerwithout regard to age, race, color, national origin, gender (including pregnancy, childbirth or medical condition related to pregnancy or childbirth), gender identity or expression, religion, physical or mental disability, medical condition, legally protected genetic information, marital status, veteran status, military status, sexual orientation, or any other factor determined to be an unlawful basis for such decisions by federal, state, or local statutes.

PIdd9513a2ae4c-26289-34645155

5 days ago
Related jobs
Promoted
TD Bank
Mount Laurel Township, New Jersey

The base pay actually offered may vary based upon candidate's skills and experience, job-related knowledge, licensure and certifications, geographic location, and other specific business and organizational needs. The Senior Audit Manager is accountable for providing specialized in-depth audit expert...

Promoted
BPO Recruit
NJ, United States

Be responsible for New Logo hunting and the sales cycle from deal origination to closure (signed contract) and successful handover to the Account Manager subsequently. Bring an understanding of the North America Energy & Infrastructure sector marketplace and competitor offerings to drive the company...

Ives & Associates
Mount Laurel Township, New Jersey

Our client is committed to preserving and enhancing the visual and environmental character of the places and communities where we work. Knowledge of principles and practices of planning, data collection; research methods, and statistics. Gather, interpret, and analyze a variety of data, and prepare ...

SUBARU
Camden, New Jersey

Subaru of America is seeking a dynamic Associate Director of Business Intelligence and Analytics to drive the strategic vision and execution of our business intelligence and analytics initiatives. The Associate Director will collaborate with various business groups and stakeholders within Subaru of ...

Maximus
Cherry Hill, New Jersey
Remote

The role of the Sr Analyst - Data Security is to provide the analytical and technical support to advance the objectives of the Maximus Information Security Office - Data Governance and Security program, promote data policies and standards, and enhance the engagement of enterprise Data Owners and Dat...

Cooper University Health Care.
Voorhees Township, New Jersey

Working with the clinical director, chief dosimetrist, and chief therapist, determine clinical implementation and improvement priorities, and, working with the Chief Medical Physicist and education and research leads, determine reports’ assignments for these projects and oversee them. We have a comm...

Byrnes & Rupkey, Inc
Mount Laurel Township, New Jersey

Our client is committed to preserving and enhancing the visual and environmental character of the places and communities where we work. Knowledge of principles and practices of planning, data collection; research methods, and statistics. Gather, interpret, and analyze a variety of data, and prepare ...

Gan & Lee Pharmaceuticals
NJ, US

Responsibilities Actively contribute to the development of regulatory strategies for investigational products in Investigational New Drug (IND)/ Clinical Trial Applications (CTA), Biologics Licensing Application (BLAs)/ Marketing Authorization Application (MAA), through evaluating scientific merits ...

Penske Transportation Solutions
Swedesboro, New Jersey

Develop and execute annual financial and operating plan, Manage the operation with integrity to meet or exceed the Business Plan targets, Identifies issues with the operating metrics and P&L and responds accordingly, Ensure customer billings and associate payroll are prepared timely and accurately, ...

BDO
Cherry Hill, New Jersey

Managers, Managers, Senior Associates, and Associates, and assists in the development of goals and objectives to enhance professional development. Managers, Managers, Senior Associates, and Associates on assigned engagements and reviews work product, as needed. Managers, Managers, Senior Associates,...