Sr Manager/ Associate Dir, Quality Systems

Sr Manager/ Associate Dir, Quality Systems

About the Company:

Dren Bio (the "Company") is a privately held, clinical stage biopharmaceutical company focused on developing therapeutic antibodies for the treatment of cancer, autoimmune and other serious diseases. The Company's management team and scientific advisors have profound expertise covering the discovery and development of specially engineered antibodies. Dren Bio's pipeline encompasses a multitude of programs from its two distinct, wholly-owned technologies. The Company's lead development candidate, DR-01, induces antibody-mediated killing of a specific cell type known to play a key role in various hematologic malignancies and autoimmune disorders. In addition to DR-01, the Company has launched multiple programs from its proprietary Targeted Myeloid Engager and Phagocytosis Platform, a bispecific antibody-based technology that offers a novel mechanism of action focused on selectively engaging myeloid cells (antigen presenting cells) for the targeted depletion of pathologic cells and other disease-causing agents.

Function:

Quality Systems

Level:

Sr Manager/ Associate Director

Location:

Foster City

Reporting Manager:

Dir Quality Systems

About the Opportunity:

The Sr Manager/ Associate Dir, Quality Systems, will manage Quality Systems, act as the main System Administrator for Veeva Quality Documents and Training applications and assist in the execution of GXP quality activities, including but not limited to creation and processing of document change control documentation through Veeva, management of standard operating procedures (SOPs), GxP record processing and archival, offsite record storage, employee training via Veeva Training, support of deviation, CAPA, and Change Control programs, GxP vendor management program, management of GxP computer systems and generation of quality metric reports. The individual will be responsible for day-to-day document control, training, and QMS activities.

Role and Responsibilities:

• Maintains Quality Systems documentation - Veeva eDMS systems

• Manage eDMS activities as required

• Lead Implementation efforts for new Veeva systems

• Maintain document trackers and indexes for GxP systems

• Develop, update, and maintain company SOPs in close cooperation with functional arearepresentatives

• Process and archive GxP records

• Support/administer GxP training including the training matrix; manage and maintainGxP employee training records - In Veeva

• Provide general support for the overall Quality System.

• Manage and continuously improve the supplier qualification and evaluation programincluding Quality Agreements

• Develop quality status reports for inclusion in management review

• Lead Quality as the 1st point of contact for GxP computer system validation andchange control

• Manage and prepare documents for offsite storage

• Managing and improving GxP documents templates used throughout Veeva

Education, Experience and Qualification Requirements:

• BA/BS in a Life Science or related field or a combination of experience and education

• Min 5 years’ Experience with eDMS and or eLMS in a pharmaceutical cGxP environment

• Experience with Veeva Vault (superuser or Veeva Business Admin), Trained SystemAdministrator preferred

• Proficient with the computer (MS Office) and internet skills

• Experience working with and formatting many file types

Core Competencies, Knowledge and Skill Requirements:

• Supports ongoing maintenance and enhancements as required.

• Assesses changes to the system (e.g. new releases) for business and training impact.

• Drive improvements and efficiencies.

• Possess and demonstrate excellent oral and written communication skills and proactiveproblem-solving, analytical, and multi-tasking skills.

• Possess the ability to work within a team-based environment while proactively forgingpositive relationships across all levels of management, departments, and suppliers.

• Quality Systems Experience in a CGMP environment

• Excellent written/oral communication skills

• Self-motivated, flexible, and able to work in a small, fast-paced, dynamic,environment

• Understanding and demonstrated knowledge of the US, EU GxP regulations a plus

• Excellent organization abilities and attention to detail

• Ability to manage multiple tasks with excellent record-keeping skills

• Excellent written and verbal communication skills

• Excellent collaborative skills

• Can do attitude

• Integrity

• Ability to work independently or in small to large teams

Salaries, Benefits and Other Employee Perks:

Dren Bio strongly believes in investing in, and rewarding, its employees. This philosophy is embodied in the Company’s total rewards program, which includes competitive cash compensation, equity incentive awards, and employer sponsored benefit offerings. The base pay range for this position at commencement of employment is expected to be between $140,000 and $180,000 per year. At Dren Bio, pay ranges are determined by role, level(s), and location. The range displayed in this job posting reflects the minimum and maximum new hire pay for candidates located across all United States job markets. Within the range, individual pay will be determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, Dren Bio’s Human Resources department can share more about the specific pay range based on the market location of the candidate.

Employment Practices:

Dren Bio is an equal opportunity employer. Employment decisions are based on merit and business needs. Dren Bio will not discriminate against any job applicant because of race, color, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, gender identity, medical condition, pregnancy, marital status, veteran status, or any other characteristic protected by federal, state or local law.