General Manager - DQA

We are urgently looking for GM -DQA For a renowned Pharma Co. to be based at Navi Mumbai location.

The Co a leading player in the discovery of new molecules both NCEs (new chemical entity) and NBEs (new biological entity) with eight molecules in various stages of clinical development. The company has a significant presence in branded generics markets across emerging economies including India.  The subsidiary also markets APIs to regulated and semi-regulated countries.

The Co. employs nearly 10,000 people in over 80 countries and with its twelve manufacturing facilities in four countries, five R&D centers and Front-ends in US, EU, India, Brazil and other markets worldwide,  is well placed on the road of growth and is exceedingly well prepared to take the completion head-on.

1, POSITION DESCRIPTION

Emp ID	--	Name	--
Role / Position Title	GM	Grade	CM1
Cadre	Services	Department/Function	QA
Country	India	Location	Navi Mumbai
Division	--	SBU	Quality
Appraiser	Head of Global Quality	Reviewer	CMD

** fill by person

2, POSITION SUMMARY

This role is Ensuring & Supporting Quality process during development of the product as per the guidelines of various regulatory authorities.

3, OVERALL JOB RESPONSIBILITIES

	Responsibility	Results Expected/ Target	% of time spent
1	Financial Health	·         Manage departmental budget to ensure planning and spending is within approved budgets and consistent with established corporate operating expense goals and in line with corporate processes. ·         Ensure to support the development process on time & within budget ·         Manage internal resources and external relationships as required to ensure 90% timely delivery of data
2	Drive sustainable growth	·         Ensure timely delivery of the product without any non compliance issue with the regulatory authorities. ·         Ensure that the facility is functioning as per the set procedure and in a compliant manner and that there are no deviations from the set procedure & regulatory requirements. ·         To implement internal audits as well as regular surveillance audits in all R&D departments ·         Support and guide preparation of responses to regulatory agency ·         Function as and when required as an expert liaison between company and external stakeholders
3	Build process excellence to manage growing complexity of operations	·         To ensure Product development as per quality requirements of various regulatory authorities. ·         Build strong SOPs to ensure a Quality approach to work ·         Ensure the coordination between formulation & Analytical formulation, API Process research & Analytical API, PKD & Clinical Research on quality aspects ·         To ensure internal Consistency and  compliance & regulatory requirements. ·         To ensure effective implantation of CAPA resulting in continual improvement
4	Build organizational capability	·         Build a strong team with scientific capability to ensure the quality systems across various stages in the R&D ·         Training and auditing Lab teams on Quality techniques to ensure best in class approaches to conclusions & assessments ·         Hire and retain best in class talent within the function with a view to build long term org capability across key therapies ·         Partnering with HR in developing and building scientific capabilities in the organization. ·         Responsible for driving career advancement plans, objective / goal setting, deciding on the KRAs for direct reports (DRs) and ensuring a similar approach for down the line reporting in the organization.

4, KEY INTERFACES / INTERACTIONS

External Interfaces	Internal Interfaces ( Other than Direct Reports)
Any external interested party for auditing system, FDA, External outsourcing laboratories, any individuals from other location for the documents requirement.	All HODs, Group Leaders, scientists

  

6, KNOWLEDGE, SKILLS AND ABILITIES

Indicate the education level, previous experience, specific knowledge, skills and abilities required to meet minimum requirements for this position.

Education (degree / diploma)	MPharm /PhD
Experience	15-20 yrs
Knowledge and Skills (Functional / Technical)	Strong understanding of the Quality Assurance/Clinical Research/Bioanalytical processes. Knowledge in Quality management for API as well formulation w.r.t. GMP, GLP requirement as laid by USFDA, EU, WHO etc. Working experience from ADL, QC, QA.
Leadership / Managerial Attributes	Should have experience to lead the team of 10 to 15 people, Good communication & presentation skills,
Other requirements (licenses, certifications, specialized training)

Salary 60 lacs but not a constraint for a suitable candidate.

Should you be interested, kindly forward your Cv at alpana@alevelplacements.com asap.