Associate Director of GMP/GLP Quality Operations at Achaogen
South San Francisco, CA, US
Position Summary:

Achaogen is seeking an experienced and highly motivated leader for the position of Associate Director of Quality Operations, reporting directly to the Senior Director of GMP/GLP Quality Assurance. The leader will be accountable for GMP Quality Operations oversight of Achaogen’s external manufacturing network and internal/external CMC development activities. In addition, the leader will develop and manage the Quality Systems and Operations infrastructure for all of Achaogen. Achaogen is preparing for a New Drug Application (NDA) submission in the second half of 2017. This role is an opportunity for an experienced GLP/GMP Quality leader to develop the policies, systems and culture necessary to produce high quality, compliant pharmaceuticals for our R&D pipeline as well as a potential commercial product.

The Associate Director will partner closely with the Director of GCP Quality Assurance and Associate Director of GLP/GMP Compliance to develop quality systems and operations that are effective and compliant for all GxP needs. The quality systems must be compliant with FDA, EU, ICH and all other applicable health authority requirements. The leader must be able identify areas of regulatory/business risks related to quality operations and compliance and be able to provide solutions to move forward.

Essential Functions:

Establish and oversee GxP quality operations, including document control, deviation reporting, training records, CAPA, change controls, etc.
Lead Quality team in the implementation and execution of Quality processes for the selection, implementation, and ongoing management of CLOs and CMOs.
Oversee the Quality Management System implementation of applicable procedures for internal use.
Responsible for drafting, negotiating and approving Quality Agreements with CMOs, CLOs and partners.
Oversee GMP quality operations at CMOs, including document control, batch record review / disposition of intermediate, Drug Substance, Bulk Drug Products, and packaged and labeled drug products.
Oversee and optimize customer complaint process.
Respond to internal /external audit findings and oversee the implementation of response commitments.
Manage internal and external deviation, investigation, CAPA, change control and compliance initiatives.
Implement and manage internal training program (including GMP, GLP and SOP training).
Support CMC development including review and approval of development reports, specifications, stability studies, method validation, process validation and material distribution activities.
Oversee product quality aspects of supply chain/distribution networks.
Oversee GMP quality aspects related to a partner’s in vitro drug monitoring device.
Provide quality support for acting as Person in Plant as needed.
Provide effective leadership including selecting key personnel and motivating members of the functional area; team member’s goal setting, performance reviews and managing the development of employees.
Provide budget support as well as setting team goals and deliverables.
Requires the ability be calm under pressure and to influence peers and cross functional team members to arrive at decisions which may be difficult.
Supports continuous improvement within the Quality Unit.

Preferred Experience:

>10 years GMP experience in the Pharmaceutical or Biotechnology industry.
>5 years GMP Quality leadership experience. Experience with CMOs, CMC development and/or QC labs is a plus.
Current and strong working knowledge of 21CFR 210-211& 820 cGMPs; ICH- Q7 and EU cGMPs; Part 11 requirements; and ICH quality and development guidelines.
Familiarity with EU – QP product release requirements.
Strong auditing experience; international experience preferred.
Experience in negotiating with regulatory bodies and advising Management on quality and compliance.
Knowledge or experience in aseptic processing environments and analytical testing, e.g. HPLC, GC, residual solvents, impurities, sterility and endotoxin testing. Parenteral therapeutic drug development and solid dosage experience is strongly preferred.
Knowledgeable in Quality Management Systems (FDA or ICH approach to risk management and QMS).
Working knowledge of third party manufacturing and contracts preferred.

Preferred Education:

Degree in chemistry, biology, chemical engineering or related scientific / technical discipline.

Preferred Additional Skills:

Professional certification in quality, compliance, or regulatory affairs.
Driven, results-oriented self-starter and excellent team player.
Creative and pragmatic approach to problem solving and issue resolution.
Well-developed critical reasoning skills combined with diplomatic interpersonal skills.
Excellent written and verbal communication skills to present to, and influence executives, peers, team members and external partners.
Able to travel domestically and internationally.
Strong leadership and interpersonal skills.
Skilled in achieving results and managing others to achieve corporate, site, and departmental objectives.
Ability to interact and gain the support of senior management.
Ability to effectively manage multiple, complex priorities.
Ability to work cooperatively in teams and peer relationships.
Committed to the values of integrity, accountability, transparency, scientific rigor and drive.
Current US work authorization required.